SIMPLIFICATION OF THE EU PESTICIDES REGULATORY...

SIMPLIFICATION OF THE EU PESTICIDES REGULATORY REGIME

Final Report

Defra 06 September 2013

In collaboration with:

2 | Simplification of the EU pesticides regulatory regime

Document information

CLIENT UK Department for Environment, Food and Rural Affairs

(Defra)

CONTRACT NUMBER PS2813

REPORT TITLE Final report

PROJECT NAME Simplification of the EU pesticides regulatory regime

DATE 6 September 2013

AUTHORS Mr. Shailendra Mudgal, BIO Ms. Arianna De Toni, BIO Ms. Lise Van Long, BIO Mr. Andreas Mitsios, BIO Ms. Valerie Fogleman, Stevens & Bolton LLP Prof. Denis Sarigiannis, Aristotle University of Thessaloniki

KEY CONTACTS Arianna De Toni + 33 (0) 1 53 90 11 80 arianna. [email protected] Or Shailendra Mudgal + 33 (0) 1 53 90 11 80 [email protected]

DISCLAIMER The project team does not accept any liability for any direct or indirect damage resulting from the use of this report or its content.

Photo credit: cover @ Per Ola Wiberg

mailto:arianna.%[email protected]

mailto:[email protected]

Simplification of the EU pesticides regulatory regime | 3

Table of Contents

A risk-based approach for the assessment 8

Scoping the protection goals 8

Targeted and prioritised data requirements 8

Zonal approach 8

The specific case of biological substances 9

Data protection issues 9

Conclusions 9

CHAPTER 1: INTRODUCTION 11

1.1 Context 11

1.2 Objectives 12

1.3 Approach and methodology 12

1.4 Document structure 12

CHAPTER 2: REGULATION 1107/2009 - GENERAL ASPECTS 15

2.1 Overview of Regulation 1107/2009The EU regime for PPPs is covered by three

major pieces of legislation: 15

THE KEY STEPS IN THE DEVELOPMENT OF THE EU POLICY ON PESTICIDES ARE

PRESENTED IN ANNEX B: LIST OF KEY DOCUMENTS REVIEWED 15

2.1.1 Main changes introduced by Regulation 1107/2009 15

2.1.2 Key issues 17

2.1.3 Review of implementation planned in 2014 18

CHAPTER 3: POSSIBLE AXES OF SIMPLIFICATION - STAKEHOLDERS’ PERSPECTIVE 19

3.1 Data requirements and methodological aspects 19

3.1.1 Data requirements 19

3.1.2 Alternative approaches 21

3.1.3 Balance in the requirements of the dossier 23

3.1.4 Unnecessary or ineffective requirements 24

3.1.5 Unnecessarily precautionary criteria 24

3.1.6 Risk management vs. restrictions and bans 26

3.1.7 Disproportionate or detrimental aspects 27

3.1.8 Simplification of aspects related to biopesticides and biological substances 28

3.2 Procedures and other regulatory approaches 29


3.2.1 EU procedures 29

3.2.2 Alternative regulatory approaches 31

3.2.3 Authorisation approaches for other potentially hazardous substances 32

3.3 Conclusions 33

CHAPTER 4: EXPERT OPINIONS ON THE POLICY OPTIONS 43

4.1 Overview of expert opinions 43

4.1.1 Option 1- Cut-off criteria – risk based versus hazard based 43

4.1.2 Option 2- Comparative assessment and substitution criteria 43

4.1.3 Option 3- Purpose of protection goals 44

4.1.4 Option 4- Periodic review of data requirements and other developments 44

4.1.5 Option 5- Data requirements (methodological aspects) 44

4.1.6 Option 6- Data requirements (nature of data) 44

4.1.7 Option 7- Environmental data requirements (scale of use) 45

4.1.8 Option 8- Data requirements for impurities and metabolites 45

4.1.9 Option 9-Data requirements and data evaluation – assessment factors 45

4.1.10 Option 10- Authorisation process: zonal approach 45

4.1.11 Option 11- Tests on vertebrate animals in data requirements 46

4.1.12 Option 12- Requirements on efficacy 46

4.1.13 Option 13- Criteria to assess risks to groundwater 46

4.1.14 Option 14- Biological substances and biopesticides 46

4.1.15 Option 15- Data protection 46

4.1.16 General comments on the rationale behind the choice of options 47

4.1.17 General comments on the feasibility of cost-benefit evaluation 47

CHAPTER 5: COST ESTIMATES OF POLICY OPTIONS 49

CHAPTER 6: CONCLUSIONS AND RECOMMENDATIONS 54

6.1 A risk-based approach for the assessment 54

6.2 Scoping the protection goals 55

6.3 Targeted and prioritised data requirements 55

6.4 Zonal approach 56

6.5 The specific case of biological substances 57

6.6 Data protection issues 57

ANNEX A: HAZARD- VERSUS RISK-BASED APPROACH IN EU LEGISLATION 59

Hazard assessment versus risk assessment 59

Classification of chemicals under EU legislation 60

Authorisation of Biocidal Products 62


Approaches in other EU legislation 66

Conclusions 71

Application of the precautionary principle 74

ANNEX B: LIST OF KEY DOCUMENTS REVIEWED 77

ANNEX C: CHRONOLOGY OF EU POLICY ON PESTICIDES 81

ANNEX D: LIST OF STAKEHOLDERS AND EXPERTS CONTACTED 89


List of Tables

Table 1: Summary of simplification axes: key elements for the stakeholders .............................. 34

Table 2: Estimated costs of the simplification options ................................................................. 49

Executive summary


Executive summary

The EU Regulation (EC) No 1107/2009 concerning the placing of plant protection products (PPPs)

on the market was adopted in 2009, and entered into force on 14 June 20111. To achieve health

and environment protection, the Regulation seeks to streamline the market authorisation

procedure for PPPs and active substances (AS), and to harmonise the related requirements.

Some of these new provisions have raised issues as they may generate additional costs,

administrative burden or other negative economic impacts for certain stakeholders, in particular

the producers and users of PPPs.

The objectives of the study were to review different aspects of Regulation 1107/2009 in order to

identify options for its simplification in line with the UK government’s Better Regulation Strategy

and, in a second step, evaluate the costs and benefits of selected simplification options. The

results of this study will help Defra in preparing its contribution to the future review of Regulation

1107/2009 due to take place in 2014.

The policy options were submitted to PPPs producers, including UK based stakeholders and EU

federations, as well as to academic experts in the field of environmental and health risk

assessment of pesticides.

The main policy options considered in the study target:

the introduction of new cut-off criteria for plant protection product active

substances replacing the current hazard-based approach with a risk-based one

and the introduction of criteria for substitution based on comparative

assessment among possible substitute substances;

the scope of the Regulation in terms of protection goals and its

implementation;

data requirements promoting a more flexible and cost-effective

implementation of the Regulation, including a move towards more integrated

testing needs and the possibility of using extensively novel approaches to data

collection including the TTC approach, read-across and computational tools

such as QSARs and PBPK models for active substance and metabolite toxicity

assessment.

the zonal approach to authorisation of active substances and plant protection

preparations

data requirements for biological substances and biopesticides

data protection issues

1 Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the

placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:309:0001:0050:EN:PDF)

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:309:0001:0050:EN:PDF

Executive summary


A risk-based approach for the assessment

Implementation of a risk-based approach for AS substance assessment is feasible assuming that

more focus will need to be given on actual exposure compared to the sole assessment of intrinsic

toxic potency of the active substances for hazard assessment (today’s paradigm). Even though

some experts have argued that such a move would increase regulatory complexity, the current

experience from the pesticide programme of the US EPA and from the REACH Regulation in

Europe shows that implementing a risk-based approach does not result in overburdened

regulatory processes and benefits towards rationalisation of the assessment process and a spur

of industrial innovation. The economic benefits would in this case not be coupled to increased

risks to environmental and human health. An adequately informed risk assessment process

would protect appropriately both the natural ecosystem and public and consumer health.

The information/data requirements for a comprehensive risk assessment would need to be

regularly reviewed and adapted to reflect scientific progress and knowledge enhancement with

regard to both the toxicity mechanisms and the fate of active substances and formulations in the

environment and the human body. Such reviews should only be done during pre-determined

intervals (e.g. every 5 or, better, 10 years) in order to ensure cost-effectiveness and the smooth

operation of both the market and the overall farming system.

Scoping the protection goals

Setting priorities in the protection goals of the Regulation including both environmental and

health aspects would also improve the efficiency of the overall system, allowing everyone to

focus resources on the most important issues. This change bears the potential for significant

savings to the overall agricultural/farming system while protecting adequately the environment

and human health. In doing that, however, care must be taken to consider not only the

ecosystem goods and services that people gain from the environment, but also the structural and

functional features of ecosystems in order to ensure their long-term sustainability.

Targeted and prioritised data requirements

Certain expensive and time-consuming tests might not be necessary if manufacturers can prove

that environmental or human exposure to the substances in question is negligible. This, however,

would have to be reviewed in the framework of an integrated testing strategy and prioritisation

exercise, which would couple exposure and toxic potency considerations to ensure adequate

protection of human and ecosystem health.

Zonal approach

Generalising the zonal approach and rendering it obligatory for authorisation is a key change that

would bring about significant cost reductions to industry and regulatory authorities, as well as

resulting in ultimate environmental benefits from the coherent implementation of assessment

Executive summary


results. A potential way to simplify procedures would be to establish a ‘one-stop-shop’ in the risk

assessment process that is followed in the implementation of the authorisation procedure. The

opinion expressed by the Community Body could be developed with the assistance of a risk

assessment expert committee, comprising MS experts. Clearly, individual MS could maintain the

right to restrict or even ban the use of AS or of commercial preparations sold as PPPs in their

territory (much like the current legislation foresees).

The specific case of biological substances

In the case of biological substances and biopesticides separate data requirements accompanied

by the provision of adequate guidance on use would be needed to ensure a cost-effective

regulatory regime. Even though developing separate data requirements would entail

administrative costs the significant efficiency gains expected from the implementation of these

requirements would be expected to reduce the net cost to minimal levels.

Data protection issues

Data protection is considered an issue that is way too sensitive to be left to industry alone to

handle. Some level of involvement of the competent authorities in the MS is deemed necessary

to ensure that no unfair market advantage is gained by specific market actors while maintaining

the quality and quantity of the data necessary for adequate human and ecosystem health

protection.

Conclusions

Based on these high-level criteria several of the policy options studied were dropped because

they were either difficult and/or unfeasible to implement, or they would incur excessive costs to

industry and/or regulatory authorities in such a way that the costs would outweigh the potential

benefits.

In conclusion, the bundle of policy modification options outlined above are considered as parts of

a feasible restructuring of the current regulatory regime in order to enhance the cost-

effectiveness of the system without jeopardising the protection to human and ecosystem health.

The overall cost of implementation of the policy options as estimated in the present study is

reasonable - the potential benefits both with regard to streamlining and simplification of the

regulatory process and with regard to spurring innovation in plant protection product

manufacturing and farming in Europe clearly outweigh the investment cost. Furthermore, the

time required for implementation is reasonable; all changes in the Regulation could be brought

about within the normal regulatory review period. The development of the necessary guidelines

for the implementation of some of the novel aspects proposed herein should not take exorbitant

amounts of time. Thus, the whole regulatory simplification procedure would not take more than

twelve to eighteen months.

Executive summary


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Introduction


Chapter 1: Introduction

his report presents the findings of the study on ‘Simplification of the EU pesticides regime’

carried out for Defra (Ref. PS2813). This introductory chapter explains the general context

underlying the study, presents the objectives of the study and the overall approach and

methodology followed.

1.1 Context

The EU Regulation (EC) No 1107/2009 concerning the placing of plant protection products (PPPs)

on the market was adopted in 2009, and entered into force on 14 June 20112. It reflects 20 years

of development of the EU’s pesticide authorisations regime. The main purpose of the Regulation

is to ensure a high level of protection of human health, animal health and the environment, while

maintaining the competitiveness of the EU agricultural sector. To achieve this, the Regulation

aims to streamline the market authorisation procedure for PPPs and active substances (AS), and

to harmonise the related requirements.

This Regulation introduced a number of changes with regard to its predecessor (Directive

91/414/EEC), including additional data requirements to assess health and environmental hazards

and risks associated with the use of pesticides. Some of these new provisions have raised issues

as they may generate additional costs, administrative burden or other negative economic

impacts for certain stakeholders, in particular the producers and users of PPPs.

The UK Government has adopted a ‘Better Regulation Strategy’3 that has as a principal objective

the removal and simplification of existing regulations that unnecessarily impede growth and

inhibit innovation. In the light of this Better Regulation Strategy, certain provisions of Regulation

1107/2009 can be questioned due to their potential for impeding growth and inhibiting

innovation while they may not necessarily increase the level of environmental and health

protection.

By December 2014, the European Commission (EC) is required to report to the European

Parliament (EP) and the Council on the implementation of this Regulation. The report has to

highlight the Regulation’s impacts on agriculture and the PPP market in terms of diversification

and competitiveness, as well as its direct and indirect effects on human health and the

environment. This review provides an opportunity for the Member States (MS) to suggest

possible options for simplification of the Regulation with regard to both the administrative and

technical aspects.

2 Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the

placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:309:0001:0050:EN:PDF)

3 http://www.bis.gov.uk/policies/bre

T

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:309:0001:0050:EN:PDF

http://www.bis.gov.uk/policies/bre

Introduction


1.2 Objectives

The objectives of the study were to review different aspects of Regulation 1107/2009 in order to

identify options for its simplification in line with the UK government’s Better Regulation Strategy

and, in a second step, to make a rough estimation of the costs and benefits of selected

simplification options.

The results of this study will help Defra in preparing its contribution to the future review of

Regulation 1107/2009 due to take place in 2014.

1.3 Approach and methodology

The work in this study was organised into three main tasks, as shortly presented below.

Task 1

Task 1 aimed to identify key issues with Regulation 1107/2009 and simplification opportunities,

through both a detailed analysis of the text and an analysis of stakeholders’ views (mainly the

producers and users of pesticide products, according to Defra’ s instructions). The focus was on

ideas for simplification that could provide similar levels of protection at lower cost to businesses.

Task 2

Task 2 consisted of a crosscutting analysis and comparison of Regulation 1107/2009 with other

relevant EU and non-EU legislative frameworks, leading to the identification of possible policy

options to improve the Regulation.

Task 3

In Task 3, the project team assessed the feasibility of conducting a quantitative cost-benefit

analysis and the data and information that would be required. Moreover, each policy option was

analysed to assess its implementation feasibility. Further, a quantitative and qualitative

assessment of the benefits and costs was carried out for each option. The assessment was based

on assumptions which are discussed in Chapter 5.

Finally, a set of conclusions and recommendations have been formulated.

1.4 Document structure

Following this introductory chapter, the report is structured as follows:

chapter 2 provides an overview of Regulation 1107/2009 ;

chapter 3 describes and analyses the possible axes of simplification based on

the stakeholder consultation and the analysis;

chapter 4 summarises the feedback of experts on the identified options of

simplification;

chapter 5 presents a cost estimation of the selected options; and

Introduction


chapter 6 presents conclusions and recommendations.

The annexes include a comparison of hazard versus risk based approaches in EU legislation

(Annex A) list of the key documents reviewed during the study (Annex B), the chronology of the

EU pesticides legislation (Annex C), and the list of stakeholders and experts contacted by the

project team (Annex D).

Please note that different terms ‘policy option’, ‘simplification axes’ or simply ‘options’ are used

interchangeably in the report and refer to the options considered in this study.

Introduction



Regulation 1107/2009 - general aspects


Chapter 2: Regulation 1107/2009 - General aspects

his chapter presents general aspects of Regulation 1107/2009 and other relevant EU

legislation, focusing on the hazard versus risk based approaches taken in those different

texts. This Chapter provides an overview of the Regulation and its main provisions.

2.1Overview of Regulation 1107/2009The EU regime for PPPs is

covered by three major pieces of legislation:

Regulation (EC) 1107/2009 which governs their authorisations and marketing;

Directive 2009/128/EC which concerns their sustainable use; and

Regulation 396/2005/EC which establishes maximum residue levels of their

residues in food and feed.

The Regulation 1107/2009 concerning the placing of PPPs on the market is at the centre of this

regime. It was adopted on 24 November 2009, and entered into force on 14 June 2011, repealing

its predecessor, the Directive 91/414/EEC. It incorporates around 100 data requirements for AS

and PPPs and a set of decision criteria (the ‘Uniform Principles’) governing the issue of

authorisations by MS. It is supported by a substantial body of subsidiary legislation and guidance.

The Regulation has two main purposes:

to ensure a high level of protection for both human and animal health and the

environment; and

to safeguard the competitiveness of EU agriculture.

The Regulation seeks to streamline the market authorisation procedure for PPPs and AS, and to

harmonise the related requirements (Article 1). The Regulation provides for a two-tier

authorisation process under which AS are approved at EU level and products, containing

approved AS, are authorised by the MS. Authorisations issued by MS must be in accordance with

the Uniform Principles to promote harmonisation. The Regulation also provides for a system of

zonal authorisations to further encourage harmonisation.

The key steps in the development of the EU policy on pesticides are presented in Annex B..

2.1.1 Main changes introduced by Regulation 1107/2009

Regulation 1107/2009 extends the regulatory provisions of its predecessor (Directive 91/414/EEC)

in a number of ways, including:

mutual recognition principle;

common authorisation of products within 3 zones;

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requirement to assess impacts on biodiversity and ecosystems;

substitution criteria; and

‘cut-off’ criteria.

The mutual recognition principle provides the possibility to place a specified PPPs on the market

in another MS and ensure the free movement of goods within the European Union.

The common authorisation of products within 3 zones is intended to avoid any duplication of

work and to reduce the administrative burden for industry and MS. The EU has thus been divided

into 3 zones (Northern, Central and Southern EU) which share similarities. When a specific PPP

has been authorised, the authorisation is valid for all the MS in the relevant zone. However, a MS

can still limit or ban a PPP in its territory if considered necessary by the competent authorities.

Regarding impacts on biodiversity and ecosystems, it is stated (Article 4) that the substance

shall have ‘no unacceptable effects on the environment, especially regarding contamination of

surface waters, (i) groundwater, air and soil (ii) impact on non-target species, (iii) impact on

biodiversity and the ecosystem’, where adequate methods exist to assess such impacts including

cumulative or synergistic effects.

Regulation 1107/2009 includes procedures and criteria for selecting candidates for substitution

(Article 50) to be included in a list that is valid for a maximum of 7 years. The criteria are listed in

Annex II point 4, and include the following (non-exhaustive list):

Acceptable Daily Intake (ADI), Acceptable Operator Exposure Level (AOEL) or

Acute Reference Dose (ARfD) significantly lower than the majority of AS

approved;

two out of the three Persistent Bioaccumulative and Toxic (PBT) criteria are

met; and

there are reasons for concern linked to neuro-toxic or immune-toxic effects, or

a potential risk for groundwater.

The pesticides identified as candidates for substitution are expected to be replaced gradually, as

less toxic alternatives become available. The substitution strategy is decided through

comparative assessment taking place at MS level. Criteria for the comparative assessment are

given in Annex IV, and include, for instance, the risk for microbial resistance development and

cost-benefit aspects.

According to the cut-off criteria, the authorisation of an AS can be rejected if it is classified as:

1A or 1B mutagenic, carcinogenic or toxic for reproduction;

an endocrine disruptor;

a Persistent Organic Pollutant (POP4);

Persistent, Bioaccumulative and Toxic (PBT); or

very Persistent and very Bioaccumulative (vPvB).

4 A POP substance is a substance having both PBT + LRT (Long Range Transport) properties



The introduction of these cut-off criteria, in particular, put the emphasis on the assessment of

hazards associated with AS (i.e. not considering exposure levels for potential targets) rather than

the assessment of risks (i.e. combination of hazard and exposure) as was the case in the previous

legislation. Reasons for the change to a hazard-based assessment in Regulation 1107/2009

include the following, in no particular order:

ten years after the Directive 91/414/EEC came into effect, only 31 of the 834 AS

that existed when it came into effect had completed the full risk-based

procedure;

evaluations of AS by the EU that were considered to be inadequate;

lack of adequate exposure data for the most hazardous AS;

lobbying by organisations such as Pesticides Action Network Europe (PAN

Europe), European Environmental Bureau (EEB); and

a study prepared for the European Parliament entitled ‘The benefits of strict

cut-off criteria on human health in relation to the proposal for a Regulation

concerning plant protection products’ (2008)5 found epidemiological evidence

that linked pesticide exposures to various types of cancer, reproductive

problems, neurological effects, and immunotoxicological effects.

The Regulation also offers the possibility (under certain conditions) to amend or withdraw the

approval of an AS if there is a conflict with the provisions of the Water Framework Directive

(WFD)6. In Annex V of the WFD, a number of substances are listed as hazardous including a

number of PPPs.

As described above, the PPPs are normally authorised for use within a specific context or

application. Regulation 1107/2009 makes it possible to ask for an extension so that existing PPPs

(on the market) could be used only for other minor uses7 that are not yet authorised under the

official procedure. Thus, a provisional authorisation for a maximum three years may be granted.

Member States are expected to report on authorised or withdrawn PPPs at least once every three

months. They also need to report every year on the scope and result of the implementation

inspections which can also be audited by independent experts.

2.1.2 Key issues

The two main objectives of the Regulation (i.e. ensuring a high level of protection for both

human and animal health and the environment, while safeguarding the competitiveness of EU

agriculture) are frequently in conflict since the withdrawal or restriction of AS in pursuit of the

first purpose may affect the second one. Conversely, a lack of stringent provisions with regard to

5 Milieu (2008) The benefits of strict cut-off criteria on human health in relation to the proposal for a Regulation

concerning plant protection products – Report for the European Parliament (http://www.europarl.europa.eu/committees/en/studiesdownload.html?languageDocument=EN&file=22471)

6 Directive 2000/60/EC

7 ‘minor use’ means use of a PPP in a particular MS on plants or plant products which are: (a) not widely grown in that

MS; or (b) widely grown, to meet an exceptional plant protection need.

http://www.europarl.europa.eu/committees/en/studiesdownload.html?languageDocument=EN&file=22471



health and environmental risks of AS, in pursuit of the competitiveness objective, may affect the

first objective.

Some stakeholders that the Commission did not carry out a formal consideration of the

implications of the cut-off criteria before the regulation was adopted. The impact assessment

accompanying the Regulation did not examine these criteria or their implications. The following

organisations criticised the cut-off criteria and the lack of these aspects in the impact assessment

conducted by the Commission:

EU Horticultural Trades Association;

European Crop Protection Association (also known as Crop Protection

Association or ECPA);

UK National Farmers Union; and

European Landowners’ Organisation.

The provisions concerning comparative assessment and substitution of products were also

subject to criticism by the industry of producers during the drafting of Regulation 1107/2009.

Together with the cut-off criteria, these provisions were criticised by some stakeholders for their

potential to result in the loss of a number of important pesticides, discouraging innovation efforts

from pesticide production companies involved in the EU market and potentially reducing crop

yields in agriculture and horticulture. These issues are further discussed in Section 3.3.

2.1.3 Review of implementation planned in 2014

By December 2014, the Commission is asked to report to the EP and the Council on certain

aspects of the regulatory framework for PPPs contained in Regulation 1107/2009 (Article 82, the

Review clause). A report will be submitted regarding the efficiency of implementation of the

Regulation, and especially:

mutual recognition of authorisations;

division of the Community into three zones; and

criteria for the approval of AS, safener and synergist components as set out in

Annex II and the impact thereof.

Although the review is formally limited to the above aspects, consideration by the Council and EP

may well extend further. In addition, the revised data requirements are under consideration and

the Uniform Principles have yet to be re-negotiated. Thus, Defra considers that there will be a

number of opportunities to review other aspects of the Regulation.

Possible axes of simplification: stakeholders’ perspective


Chapter 3: Possible axes of simplification - Stakeholders’

perspective

his chapter presents a summary of stakeholder responses to the questionnaire used to

collect their opinions on the simplification of Regulation 1107/2009, complemented by the

analysis carried out by the project team. Questions asked to the stakeholders are

presented in boxes in the sections below. The key findings of the analysis are presented in the

form of a summary table at the end of this section.

The aim of this consultation was to identify the aspects of the current regime that may cause

excessive adverse economic impacts, especially on pesticides producers and users, such as

administrative burdens, compliance costs, competitiveness issues, uncertainty issues, etc., while

not providing a significantly higher level of health and environmental protection.

3.1 Data requirements and methodological aspects

3.1.1 Data requirements

Are there data requirements that are not crucial to regulatory decision making or could be

reduced without significant impact? If YES: Which ones and why?

In general, the consulted stakeholders are very critical of the data requirements in Regulation

1107/2009, and they implicitly criticise the risk assessment process itself. One of them suggested

that first the risks that need to be managed should be identified, based on exposure estimates

(e.g. UK model for Operator Exposure), then the current data requirements used in risk

management could be identified. For instance, in the case of exposure to endocrine disrupting

chemicals (EDCs), the contribution of pesticides to overall human or environmental EDC burden

is considered to be negligible compared to other products such as pharmaceuticals; thus,

evaluation of the endocrine disrupting potential of pesticides and possible restrictions will

probably have a limited value.

In the consultation process, stakeholders suggested several amendments related to the data

requirements. Specifically, some stakeholders argued that the following data requirements are

not necessary and should therefore be removed (including information on substances and

products):

metabolism, distribution and expression of residues in fish (as described in

SANCO/11802/2010, section 6.2.5);

feeding studies in fish (as described in SANCO/11802/2010, section 6.4.4);

rotational crops residues (second tier) (as described in SANCO/11802/2010, section

6.6.2);

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aerobic mineralisation in surface water (as described in SANCO/11802/2010,

section 7.2.2.2 and SANCO/11803/2010, section 9.2.1);

the 18-month mouse carcinogenicity study, considered to be redundant with other

studies that are equally health protective;

repetition of residue data if use pattern reduced;

residue data and efficacy data for minor uses; and

efficacy data when a new formulation containing an old active substance is

presented, for which no new rates or claims are put forward.

Stakeholders also quoted the UK NC3Rs work on the lack of need for aspects of acute toxicity

testing regarding dermal intake and inhalation.8

The required efficacy trials and Good Agricultural Practices (GAPs) in compliance with updated

EPPO standards9 for efficacy evaluation of PPPs could be removed during Annex I revision,

especially for substances that have been on the market for many years.

Another point raised by the stakeholders is the lack of clarity and guidance on the data

requirements, which can lead to a massive increase in vertebrate use in toxicology. For instance,

the guidance on dermal penetration excessively restricts the potential to make a link from one

formulation to other ones having the same active ingredient. This leads to additional work such

as the need for more vertebrate testing on an endpoint for which there is already a scientific

consensus.

The project team suggests that the environmental protection goals of Regulation 1107/2009 be

specified in order to allow efficient implementation and monitoring of compliance; in the current

Regulation, these goals are too vague. It would be very important to specify the impact on

biodiversity and ecosystems in the revised Regulation together with the protection goals. For

this, specific quantitative indices of animal and plant species like the Shannon Index could be

used and a specific guidance could be provided in the revised Regulation. Maintaining critical

ecosystem functions is also important. In the analysis of the potential impacts on ecosystems,

the question of ecosystem function resilience needs checking. The most critical of these

functions should not be irrevocably disrupted by the entry of the AS being assessed into the

environment.

Another absent aspect is the evaluation of the cumulative or synergistic effects of multiple AS on

human and animal health. These effects are even more important when these substances can be

bioaccumulated or biomagnified. For these reasons, the project team would suggest not

eliminating the data requirements on such effects based on well-defined exposure scenarios.

Recent studies show strong dose-dependence of more than merely additive behaviour of

chemical mixtures in the environment. A tiered approach that would look at the mode and

8 Stuart Creton, Ian C Dewhurst, Lesley K Earl, Sean C Gehen, Robert L Guest, Jon A Hotchkiss, Ian Indans, Michael R

Woolhiser, Richard Billington. Acute toxicity testing of chemicals-Opportunities to avoid redundant testing and use

alternative approaches. Crit Rev Toxicol. 2010 Jan ;40 (1):50-83 20144136. National Centre for the Replacement,

Refinement and Reduction of Animals in Research (NC3Rs), London, UK.

9 Standards issued by the European and Mediterranean Plant Protection Organization



mechanism of action of the considered substances first, and then decide whether there is scope

for investigation of cumulative effects, would be an efficient and cost-effective mechanism to

adequately protect the environment and animal and human health.

3.1.2 Alternative approaches

Are there scientific innovations which could replace reliance on costly field or laboratory

studies with e.g. in vitro methods or other, more cost effective, alternatives in any areas? If

YES: Which ones? What would be the advantages and possible drawbacks?

A wide range of scientific innovations were highlighted by the stakeholders, which could

constitute different means of improving the balance between the cost of the risk assessments

and the delivery of useful results. This aspect seems to be perceived by the stakeholders as

particularly important.

The consulted stakeholders suggested that additional elements could be taken from some

national requirements e.g. UK OPEX, the UK surface water and groundwater modelling, the

Toxicological Threshold Concentration (TTC) or the US approach of eliminating the efficacy data

(i.e. let the market decide if a product is efficient based on sales results).

The Agricultural Chemical Safety Assessment (ACSA) approach can also improve the assessment

process by reducing the number of requested tests that are carried out to define the duration and

extent of exposure to substances. This method is currently under development and needs

validation; however, by 2014, it will be at a sufficiently advanced stage to be considered in the

discussion for the revision of Regulation 1107/2009.

One stakeholder commented that there is often a lack of acceptance of costly field studies, while

there is some reliance on the conservative interpretation of laboratory studies, even though the

results of field studies are closer to the real situation. Results from field studies should be given

more importance than results from in vitro studies, but this does not appear to be the case for the

moment.

Stakeholders proposed different possible solutions to avoid expensive field studies, including the

use of ecological modelling (population modelling) or the introduction of a sensitivity analysis to

identify key species and areas of the environment to be monitored.

Alternatively, in-vitro tests can be used (or provide the basis) for the assessment of the acute

formulation endpoints and for the evaluation of the pathogenic potential of putative biocontrol

strains (e.g. using Caenorhabditis elegans10).

For tests related to acute toxicological effects, the use of laboratory animals could be reduced

significantly by adopting the revised testing scheme advocated by ILSI/HESI (International Life

Sciences Institute - Health and Environmental Sciences Institute). Accordingly to stakeholders,

10 Zachow et al., 2009. The Caenorhabditis elegans assay: a tool to evaluate the pathogenic potential of bacterial

biocontrol agents Eur J Plant Pathol (2009) 125:367–376. Meaningful conclusions can be drawn based on the DNA profile of a micro-organism’s toxicity.



this process does not compromise the assessment of the critical endpoints in the human risk

assessment, it avoids the production of unnecessary data.

The project team considers that the integrated use of human, experimental (both in vivo and in

vitro) and computational data is a rational way towards reducing the cost and administrative

burden of testing, limiting the number of laboratory animals used for these tests and ensuring

the adequate public and occupational health protection. In vitro methods could be used to

replace field or laboratory studies if properly validated for the specific health endpoint of interest.

Currently, the largest number of test animals is used to assess reproductive toxicity (the 2nd-

generation test) for which existing alternative in vitro methodologies (e.g. European Centre for

the Validation of Alternative Methods (ECVAM) work) could be taken into account in the revision

of Regulation 1107/2009.

In vitro methods could be more effective and reliable, when coupled with in silico methods,

including a combination of physiology-based biokinetic and biodynamic models with

Quantitative Structure-Activity Relationships (QSARs). The former allow estimation of the

internal (and to the extent possible, the biologically effective) dose of the active substance in the

target tissue of the whole body (appropriate for evaluation of systemic effects). The latter allow:

(a) an estimation of biokinetic, partitioning and other physical/chemical properties of the

active substance on the basis of its molecular structure and the active chemical groups –

they are even more reliable when the stereoscopic structure of the substance is taken into

account; and

(b) an assessment of the toxic potency of the active substance for specific health endpoints

associated with the presence of certain chemical groups in the overall chemical structure of

the substance. They would require extensive validation to be used separately, but they

could be used for screening purposes on the basis of their toxicological predictions. They

would be better used in a structured framework that brings together additional pieces of

information regarding human health hazard potency of the active substance.

With regard to human data, both clinical and epidemiological data should be used:

clinical observations are used in chemical safety legislation in order to provide

phenotypic anchoring of toxicological laboratory tests, which are used for

translating these lab data into mechanistic hypotheses on the mode of action

of AS. They can also be used to provide early alerts of physiological effects that

might not have been observed in laboratory testing (this may be the case due

to differences in physiology and metabolism between test animal species and

humans). However, these observations (or absence of visible clinical effects)

cannot be used to offset the results of animal experimentation with regard to

toxicity. Clinical observation may not provide the appropriate phenotypic

evidence of the onset of adverse health effects because of the existence of

defence mechanisms in the human body and variability in physiological

response to toxic insult among the human population.

epidemiological studies may provide valuable evidence on the actual human

relevance of the toxic potency of AS and commercial preparations of PPPs.

However, on many occasions these studies are not structured well enough to



provide the statistical robustness that would be needed to accept the

conclusions of epidemiological studies. Thus, only very well designed

epidemiological studies can be used to override data from toxicological tests.

The development of computational tools such as physiology-based biokinetic

models would allow a more scientifically robust translation of animal data into

information relevant for humans, and conversely, the use of human (clinical or

epidemiological) data to support or reject mode of action hypotheses built on

the basis of animal testing.

3.1.3 Balance in the requirements of the dossier

Is the overall dossier required balanced in the sense that the data required and the decision

criteria are proportionate when benchmarked against other areas of the risk assessment?

In general, the current focus of the evaluation process is perceived by stakeholders to be too

precautionary and not proportional to the risks that need to be managed; they consider that it is,

rather, influenced by the political context. In particular, the data requirements on environmental

fate are considered to be excessively demanding.

Environmental risk evaluation is perceived as often resulting in highly conservative assessments

for both consumers and the environment with no clear links with protection goals (e.g.

multiplying extreme consumption patterns together, looking at impacts on individuals rather

than on animal populations, selecting too vulnerable aquatic species). If taken individually, input

parameters of the environmental fate modelling can be regarded as precautionary and realistic;

however, when combined they become unrealistic and excessively conservative. According to

the stakeholders, an improvement could be achieved by accepting human-based data and

refining the toxicological endpoints (i.e. OPEX human data).

In addition, the project team considers that the automatic characterisation of category 2

carcinogens or reproductive toxicants as endocrine disrupters foreseen in Annex II, point 3.6.5, is

disproportionate with regard to the definition and treatment of endocrine disrupting substances

in other risk assessment legislation, including REACH (an accepted definition of endocrine

disruptor is not yet available). Additional analysis should be made to investigate the mode of

action (with regard to carcinogenicity and/or reproductive toxicity) of these substances and check

whether their mode of action is really through endocrine disruption before characterising them

as such.

Another example of imbalance is that various micro-organisms are considered in eastern EU

countries under the local fertilizer law, supported by DG-ENTR, whereas western EU countries

consider them as PPPs under Regulation 1107/2009 supported by DG-SANCO.



3.1.4 Unnecessary or ineffective requirements

Are there requirements which seem unrealistic or unlikely to produce worthwhile benefits? If

YES: Which ones and why?

The stakeholders identified several requirements that seem to increase workload and complexity

without producing valuable benefits. These mostly relate to vague definitions (e.g. ‘any product

that influences life processes of the plant’), excessive data requirements (i.e. on metabolites) and

hazard cut-off criteria as mentioned above.

Other areas mentioned by the stakeholders concern the assessment of the candidates for

substitution and the required comparative assessment. A large number of AS may be classified as

candidates for substitution, which may lead to an excessive number of comparative assessments.

According to stakeholders, this substantially increases the workload for industry and regulators

without increasing the safety of products on the market. This can potentially impact the

introduction of new AS in the EU, without increasing the safety of products that are currently

placed on the market.

Moreover, the requirement to conduct comparative in vitro metabolism assessment across

species is not considered as scientifically robust and relevant to the protection of human health.

Similarly, the forthcoming EFSA soil risk assessment scheme11 is regarded as too complicated,

and not taking into account important ecological criteria in its current form. In general, the

investments required to address these requirements are not considered to be proportional to the

potential risks from these compounds.

The project team also notes that the use of the terms ‘significantly’ in criteria (a) and ‘significant’

in criteria (b) of Article 50-1 introduces uncertainty and fuzziness in the implementation of the

Regulation. These criteria ought to be much more precise than what is described in the current

regulatory text. If this cannot be done, then the criterion may need to be removed. Otherwise,

this may be a source of confusion in its practical implementation.

3.1.5 Unnecessarily precautionary criteria

Are there decision criteria that are unnecessarily precautionary? If YES: Which ones and

why?

With regard to the cut-off criteria, a stakeholder recommended that a clear distinction should be

made between the precautionary principle and the preventive principle. The precautionary

approach in the evaluation process (e.g. the cumulative risk assessment; exposure concentration

of toxicants causing a defined effect on 10% or 20% of a test population (EC10, EC20, and the

conservative modelling) could be reconsidered and be more risk-based than hazard-based. This

may encourage innovation in the crop protection industry.

11

http://www.efsa.europa.eu/en/efsajournal/pub/1820.htm

http://www.efsa.europa.eu/en/efsajournal/pub/1820.htm



With regard to generic products, it was argued that comparability cannot always be established

with reference products. More specifically, it was pointed out that worst-case scenarios are not

always applicable. In addition, for the same category of products, the data protection measures

are not always clear and a different interpretation is often given in different MS.

The maximum pesticides threshold in groundwater (0.1 µg/L) is regarded as unreasonably

precautionary by several stakeholders, considering that such a limit value is derived from a very

conservative modelling that takes pore water at 1 m depth as the output for decision making for

groundwater. The aquatic risk assessment is thus perceived as unnecessarily precautionary

because it entails a combination of worst-case exposure with worst-case endpoints and often

worse-case safety factors, even when higher tier studies are presented.

Similarly, aspects related to the testing design, the ECHA classification and subsequent

regulatory decision making (e.g. ECETOC12 work on potency) are perceived as unnecessarily

precautionary.

The fact that cut-off criteria and the hazard-based classification take no account of potency is

also perceived as unnecessarily precautionary. The same applies to the use of precautionary

classification decisions in regulatory decision making.

The cut-off criteria defined in Regulation 1107/2009 may have a significant impact on the final

results of the assessment of products and a significant number of approved AS (as per the Annex

I of the 91/414/EEC Directive) may have to be withdrawn. Some categories of pesticides may be

especially concerned (e.g. insecticides)13. An estimate of the likely evolution of the types of

pesticides used in the EU was provided by Karabelas et al. (2009)14. The study suggests that a

significant number of AS (available on the market) could be characterised as toxic under the new

cut-off criteria; 84 out of 276 AS present at least one criterion. However, there may be debates on

how to interpret some of the cut-off criteria (e.g. the endocrine disruption potential). Economic

consequences of the implementation of further assessment criteria may adversely affect

pesticide producers (additional costs for producing the required data and conducting further

R&D, business uncertainty, etc.), farmers (crop losses due to the lack of efficient products

withdrawn from the market, need for costly alternative methods, etc.) and public authorities

(increased workload associated with the assessment of dossiers).

The new cut-off criteria and other regulatory changes will most probably lead to additional AS

withdrawals up to 2014, as discussed above. This, combined with the rather small rate of new AS

introduction (approximately 5 per year) suggests that the list of approved AS over the next 10–15

years may not change drastically14 (this means that the estimated rate of AS withdrawn from the

market on the basis of the application of the current hazard-based criteria would be almost

replenished by the introduction of new AS). It must be noted, however, that the importance of

12 European Centre for Ecotoxicology and Toxicology of Chemicals

13 Pesticides Safety Directorate (PSD) (2008). Revised assessment of the impact on crop protection in the UK of the

‘cut-off criteria’ and substitution provisions in the proposed regulation of the European Parliament and of the council concerning the placing of plant protection products on the market. York, UK

14 Karabelas A.J. Plakas K.V. Solomou E.S. Drossou V.. Sarigiannis D.A (2009) Impact of European legislation on

marketed pesticides — A view from the standpoint of health impact assessment studies. Environment International 35, 1096–1107



AS for plant protection is what matters, not just the total number of AS available per se. Based

on recent estimates, specialist crop growers could be left with less than 100 AS available14. A

main concern is that fewer active ingredients may lead to problems for farmers and the food

industry in producing high quality crops in a cost efficient way, if sufficient protection against

some pests cannot be achieved, or if the low variety of products available leads to pests

developing resistance to pesticides. For example, on oilseed rape, the removal of a range of

fungicides would not leave any fully effective compounds to fight major diseases15. Different

parts of the agricultural sector may then be affected to varying degrees. Though it is expected

that the removed products would be replaced by new ones posing a lower risk, it is far from

certain that replacements as efficient as the previous ones are readily available in all cases for

market introduction.

Other effects may include a reduced incentive for innovation within the PPPs industry if, due to

the costly and complicated procedure, small companies have difficulties finding resources for

introducing new substances on the market. Thus, it may be difficult for innovative solutions to

reach the market. In a second step, adverse effects may occur for example on employment, rural

development or crop diversity.

3.1.6 Risk management vs. restrictions and bans

Are there areas where risk management options could replace restrictions or outright bans

on a pesticide? If YES: Which ones and how?

In general, the stakeholders consider that exposure is not sufficiently taken into account in the

current framework. For example, some types of uses are perceived as not leading to

environmental exposure for some environmental compartments or classes of organisms (in this

case, restrictions could be re-considered), either because of the nature of the pesticide or

because of the implementation of risk mitigation measures. Thus, a greater acceptance of all

available risk management options could be promoted and implemented at a national level. The

choice of the best options would require inputs from all stakeholders and a harmonised guidance

for mitigation actions could be provided (e.g. actions to limit run-off or to use drift reduction

nozzles). It is then suggested that a restricted approval considering risk management measures

could be put forward as an alternative to prohibition. This would also be similar to the current

REACH framework.

In the current framework, restrictions or bans can be decided based on low efficacy of the

products. However, the use of certain low efficacy products as preventive pesticides could be

justified in certain cases; while their use may not be sufficient to stop the pathogens, it may still

contribute to reducing further application of more efficient chemicals.

15 Pesticides Safety Directorate PSD, Revised assessment of the impact on crop protection in the UK of the ‘cut-off

criteria’ and substitution provisions in the proposed Regulation of the European Parliament and of the Council concerning the placing of plant protection products on the market Pesticides Safety Directorate (2008) www.pesticides.gov.uk/Resources/CRD/Migrated-Resources/Documents/R/Revised_Impact_Report_1_Dec_2008(final).pdf

http://www.pesticides.gov.uk/Resources/CRD/Migrated-Resources/Documents/R/Revised_Impact_Report_1_Dec_2008(final).pdf

http://www.pesticides.gov.uk/Resources/CRD/Migrated-Resources/Documents/R/Revised_Impact_Report_1_Dec_2008(final).pdf



The move to a hazard-based assessment goes in the opposite direction to other EU legislation on

chemical safety, such as REACH. The latter introduces exposure as a key determinant of

potential risk to human health and the environment. Exposure (expressed in terms of tonnage

entering the EU market each year) is the key criterion for clustering chemicals and determining

data requirements. Exposure (low) can also be an argument on the basis of which certain

toxicological tests can be waived.

The main requirements that go beyond the risk assessment principles applied in REACH pertain

to cumulative or synergistic effects of AS and PPPs. In the case of AS used in plant protection,

this is warranted due to the high probability that several AS may be used on the same or similar

plantations. Residues of such chemicals may, therefore, enter the food chain and, especially

when they are bioaccumulative and persistent (or very bioaccumulative and very persistent), may

have non-linear (synergistic) effects on human and ecosystem health.

To date, there has been a significant paucity in reliable quantitative exposure data for PPPs.

Currently, however, new computational techniques involving both computational modelling and

read across methods (to fill the observed data gaps) can be used to improve upon exposure

estimates.

Thus, the revised Regulation could easily avoid the current cut-off criteria (only based on

toxicological properties) and introduce more refined exposure estimates as co-determinants of

actual risk.

3.1.7 Disproportionate or detrimental aspects

Are there aspects of the EU pesticides legislation that you consider are disproportionate or

detrimental? If YES: Which ones? What do you consider to be the negative implications?

As regards the provisions that relate to the candidates for substitution and the comparative

assessment, stakeholders argue that these severely increase the regulatory burden but do not

significantly increase the level of protection for human health and the environment.

For example, a new active substance with an excellent risk profile may trigger two out of three

Persistent Bioaccumulative and Toxic (PBT) criteria. Consequently, a company may be unwilling

to invest in and introduce such an active substance in Europe as this substance would directly

become a candidate for substitution and would be under a high level of scrutiny on a permanent

basis. This may have a negative impact on innovation, leading to reduced investment in new

PPPs in EU.

Also with regard to classification, it was pointed out that this process is distinct from the

evaluation of the active substances, and that the outcomes are over-conservative (e.g. the risk

phrases R40 (limited evidence of a carcinogenic effect) and R63 (possible risk of harm to the

unborn child) are not considered as solid scientific classification categories). This issue leads to an

excessive number of tests on vertebrates, which are carried out to address metabolite safety (see

also previous considerations on testing).



The above issues may lead to a loss of useful products. The over-conservative outcomes could

also cause an over-labelling of PPPs, making it impossible for users to judge the real properties of

a product.

As regards flagging issues to the Risk Assessment Committee (RAC), it was argued that EFSAs’

intention to make RAC aware about specific points by developing a proposal of a very

conservative classification often leads to the adoption of this classification, as there is no voting

process in the finalisation of the RAC meetings. A consensus is assumed if none of the members

actively opposes a proposal.

As mentioned above, it was highlighted that the risk assessments often include several worst-

case assumptions which result in compounded conservatism and an unrealistic outcome.

Compounded conservatism needs to be reduced to achieve a protective but more realistic

outcome. In addition, post-registration monitoring (e.g. on groundwater) could be implemented

in areas where confirmation of an acceptable outcome needs to be demonstrated. Other aspects

considered as disproportionate are the EU approach on MRLs (it is suggested that an automatic

adoption of the Codex MRLs could be considered) and the UK policy on insecticide mixtures.

3.1.8 Simplification of aspects related to biopesticides and

biological substances

Although the questionnaire did not contain any specific question on the issue of biopesticides

and biological substances, a number of stakeholders commented on possible areas for

improvement in relation to these products and substances.

The safer nature of this category of substances should be acknowledged and their use

encouraged. Stakeholders that produce biological substances and products (produced from

naturally occurring organisms and/or substances) and biopesticides argued that the current

system is a ‘ ‘one size fits all’ ‘ and, for this type of product in particular, there is a strong

argument for establishing specific procedures, also including a clearer definition of waiver

guidance.

These procedures could be initiated by recruiting specialist regulators who have the necessary

knowledge and skills. This would allow simplification of the authorisation process for these types

of products, avoiding the need for constant re-interpretation as in the current process. If the

guidelines were more suitably tailored for these categories of products, the process would

become clearer and more streamlined. In addition, less time would be needed by the applicants

to prove why certain guidelines are not applicable or suitable.

More specific standardised procedures could be developed based on the OECD guidelines, or

based on the US EPA approach where all biological products are accepted unless it is proven their

use is not safe. In the USA, this has resulted in a far greater number of biologically derived

products available when compared to Europe. The Canadian system, although more detailed

than the one promoted by the US EPA, also demonstrates a more pragmatic approach leading to

a higher number of biological products on the market.



A possible option could be to base the assessment on the inherent risk associated with the

natural component and its actual formulation, rather than upon the intended use as currently is.

An example provided by a stakeholder is the use of pheromones for traps and monitoring.

Current regulation regards these substances as safe without the requirement for a detailed risk

assessment. When the same substances are used for mating disruption, they have to follow

detailed risk assessment procedures. Another example provided refers to biological substances

used as bio fertilizers, which only require a limited regulatory procedure for such use, but when

similar substances are used as pesticides they must follow a far more detailed risk assessment

procedure. It is then argued that, in such cases, an active ingredient dossier should not be

required and a formulation file could be sufficient instead. However, it might be difficult to follow

this approach at the national level.

One stakeholder pointed out that, in eastern EU countries, various micro-organisms are covered

by the local fertilizer laws (supported by DG-ENTR) whereas western EU countries consider these

organisms as PPPs which are covered by Regulation 1107/2009 (supported by DG-SANCO).

3.2 Procedures and other regulatory approaches

3.2.1 EU procedures

Are there areas where EU procedures could be improved? If YES: Which ones? What would

be the benefits?

Stakeholders recommended a more predictable and consistent assessment and a review of the

Regulation which would facilitate investment decisions on new products. In addition to what has

already been discussed, the following suggestions can be highlighted:

a comparison of risks and benefits should be considered. Given the increased

importance of food security and sustainability, a greater emphasis on societal

benefits could be incorporated into the decision making process as well. The EC

could ensure a higher level of predictability for the industry, notably through an

impact assessment of new legislation.

the time needed to deliver a dossier needs to be considered (e.g. in the renewal

process of an approval). In addition, in the regulatory process the crop industry

should be considered as a key stakeholder.

a better understanding of the ‘agricultural environment’ should be promoted. For

example, this could be achieved by accepting that irrigation channels are for water

management and should not be regarded as ‘ecological habitats’ (e.g. protection

of non-target aquatic plants in waterways that are regularly dredged to maintain

flow).

It was also pointed out that there is a lack of clarity on the role of EFSA in relation to the

classification recommendations as those have been defined by the ECHA mandate. Specifically,

in relation to the EFSA guidance development, the following issues were pointed out:



there is insufficient opportunity for industry experts to be engaged in the guidance

development;

there is a lack of transparency in EFSA evaluation processes;

the current process results in a low predictability for industry;

the independence of EFSA must be ensured and, most importantly, quality of

guidance could be improved;

the implementation timelines for the new guidance is unclear: the new guideline or

criteria were adopted retrospectively ; and

the product renewal for mixtures is unnecessarily burdensome.

It was also argued that higher tier data needs to take precedence over lower tier data based on

expert scientific judgement. It would be more effective if EFSA made decisions on higher tier

data, rather than reverting only to the guidelines.

Regarding the zonal approach, it is seen as a more complex rather than a more harmonised

process. A stakeholder suggested that the current system should be replaced with a common

European registration system similar to what exists for pharmaceutical products. Similarly, it was

suggested that the degree of subsidiarity allowed could be reduced and the new zonal

authorisation principles would need to be strictly applied.

Requirements could be established on confirmatory data, and on the clarity of data in areas

where no fixed guidelines are available. In addition, a major issue is the lack of consistency

among assessment processes conducted by MS, which generates uncertainty for the industry. It

remains common for individual MS to request additional or different information outside the

original dossier submissions (e.g. residue monitoring and groundwater monitoring are not used

in Denmark). In this regard, it was pointed out that difficulties often occur not because of the

preparation of studies but because of the uncertainty on how these studies will be assessed by

the MS. The requirement for providing copies of the registration files is generally perceived as

time consuming and expensive.

The selection of the Zone Rapporteur Member State is not regarded as a fair and transparent

process. It is considered that some MS do not have sufficient means to evaluate the zonal

dossiers and Article 38 (according to which specifications need to be submitted to several MS)

has not been applied as much as necessary. In addition, it was pointed out that Article 62 should

be more precise. For some registration demands (e.g. extension label, change of condition of use,

change of formulation) a clear process has not been defined. It was also argued that procedures

related to MRLs need a long time to be completed.

Under the current system, applications for AS approval and renewal are submitted to a specific

Rapporteur Member State. Stakeholders argued that it increases the workload – at least in some

MS – and may result in a duplication of efforts since EFSA also conducts a review. This may lead

to an inconsistent level of fees and quality of work. If, alternatively, the responsibility for the

preparation of the evaluation was administered through a single EU body, the process could be

more efficient; it would reduce the number and length of delays and issues would be addressed in

a consistent manner, with reasonable fees and a good quality of dossiers. The review process



could be carried out by a single agency, for example following the model of the European

Medicinal Products Agency. In general, under the current system, there are many evaluations

foreseen in a short timeframe and insufficient resources in both authorities and companies.

The process of AS renewal is currently seen as unpredictable, inefficient and complex for both

industry and the authorities. Currently, the authorities do not have sufficient time to process the

dossiers under the zonal approach.

The situation could be significantly improved through the introduction of a data call-in process

which would include mandatory data sharing. This would ensure that applicants only conduct the

studies required and, consequently, there would not be an unnecessary duplication of data

generation. This would also ensure that all applicants would contribute fairly to the costs of AS

data generation.

3.2.2Alternative regulatory approaches

Are there alternatives to the regulatory approach in any area? If YES: Which ones? What would be

the pros and cons?

A range of alternative regulatory approaches have been mentioned by the stakeholders, as

presented in the previous section. In addition to those, the following suggestions were made:

the mutual recognition between MS should be compulsory;

the data compensation should follow an arbitration process; and

the level of efficacy should be decided by the market.

As regards the harmonisation process which is proposed in the guidelines, it was argued that a

desirable level has not been reached yet, because the development of models drifts away in

several directions and several MS can have different views (e.g. on the evaluation of a specific

dossier). For this reason, the process could be simplified by developing a standard risk

assessment process for all affected stakeholders (operators, workers, bystanders and residents).

With regard to risks to groundwater, the evaluation could be based on a risk assessment and

abolish the current system which is based on the arbitrary cut-off criteria for the AS and the

established guidance for the assessment of relevant metabolites. This would significantly reduce

the regulatory burden without having negative impacts on the protection of human health or the

environment. However, this process might not receive a wide acceptance by the public.

With regard to risks to micro-organisms, it was argued that, as long as the soil is treated with

microbials, these substances could be considered as a fertiliser. If the microbial contains (micro)

nutrients, the substance could also be considered as a fertilizer, even when sprayed directly on

plants. Depending on the label claimed, a choice could be made to either consider the substance

as a PPP or as a fertilizer. The same could apply to natural substances and biopesticides.



Non-EU authorisation approaches

Are there pesticides authorisation approaches implemented in non-EU countries that you

find less regulatory whilst achieving a similar outcome? If YES: In which countries? What are

the main advantages? Would this be transposable to the EU?

The stakeholders pointed out a number of relevant approaches, most of which are implemented

in the USA:

the US approach which allows the market to decide on efficacy aspects;

the limits on groundwater which derive from a risk based approach and the WHO

safety guidelines;

the risk assessment approach followed in the USA;

the acknowledgment of the benefits of pesticides to food production; and

the data call-in requirements issued by the US EPA.

The US system is perceived as open, transparent and science-based with less political

interference. The US EPA completes the registration reviews on time and the Pesticide

Registration Improvement Renewal Act (PRIA) has been a significant improvement. It is argued

that in the EU there seems to be little or no accountability for meeting commitments.

In addition, according to a stakeholder, in Japan, the US and many other countries, the concept

of cut-off criteria based on a hazard assessment has not been applied. However, the outcome in

terms of human health and environmental protection is similar.

3.2.3 Authorisation approaches for other potentially hazardous

substances

Are there authorisation approaches implemented in the regulatory schemes for other

potential non-PPP pollutants/contaminants/chemicals you find less regulatory whilst

achieving a similar outcome? If YES: Which substances are regulated? In which countries

and under which EU regulation (if relevant)? What are the main advantages? Would this be

transposable to pesticide regulation?

The REACH Regulation was provided as an example of an exposure driven legislation through

which a minor use or volume of products can influence the data requirements. REACH is

perceived as a good example where a complex regulatory scheme is implemented at the EU level

with a good balance of benefits and costs of implementation and which does not impose

unnecessary burden to industry.

Pharmaceuticals were also often quoted as subject to a much less burdensome regulatory

regime, even although they are arguably more biologically active than pesticides, and are found

in higher concentrations in the environment and especially in water.



3.3 Conclusions

A summary of simplification axes for the simplification of Regulation 1107/2009 is provided in

Table 1 below. It is based on the analysis of legal and scientific aspects of the Regulation carried

out by the project team and the analysis of opinions expressed by the stakeholders.



Table 1: Summary of simplification axes: key elements for the stakeholders

No. Targeted legal requirement

Ref. Possible revision and rationale Qualitative analysis Feasibility aspects of the option in terms of cost

benefit evaluation and possible implementation

1 Cut-off criteria – risk based versus hazard based

Annex II, points 3.6 & 3.7, others?

Revision:

Revert to a risk assessment approach, by considering exposure in addition to intrinsic hazard properties

Rationale:

The risk-based approach is also followed in other EU legislation (e.g. REACH). The recent adoption of the exclusion criteria in the Biocidal Products Regulation might make the implementation of this option more difficult. Nevertheless, the exceptions in the Biocidal Regulation are broader than Regulation 1107/2009 in relation to the use of an active substance that is banned.

NB: With regard to classification as endocrine disrupter, no change will be proposed in the present study as there is a parallel study on this issue.

Benefits for stakeholders:

Avoid a decrease in the number of authorised AS and availability of PPPs in the future; Products that were banned under the cut off criteria could be classified for restricted use

Avoid revenue losses for PPP manufacturers

Avoid possible reduction in crop yields in agriculture and horticulture due to a lack of efficient PPPs on the market (affecting farmers and possibly also food prices for consumers)

Having more resources for innovation (due to R&D costs) for PPP manufacturers

Costs:

Minimal costs of health and environmental damage provided the risk assessment is robust and products used correctly.

Evaluation feasibility

Information on exposure is necessary to identify those AS for which a risk-based approach could conclude that the risk is negligible.

Some exposure data available but are fundamental difficulties in evaluating costs for possible environment and human health impacts. These difficulties are common to many of the options in this paper.

This may also require the implementation of procedures to share exposure data among MS. Economic (cost saving = benefits) and possible legal aspects of a mechanism which would allow the data sharing, would also need to be evaluated.

Possible difficulties in evaluating specific damages

2 Comparative assessment and substitution criteria

Art 24 & 50 & 80.7

Annex II, point 4

Revision

The use of the terms ‘significantly’ in criteria (a) and ‘significant’ in criteria (b) of Article 50-1 introduces uncertainty and fuzziness in the implementation of the Regulation. These criteria ought to be more precise and be set to identify only a manageable proportion (say 10-20%) of active substances.

Rationale:

There is a large number of AS which may be classified as candidates for substitution and may lead to an excessive number of comparative assessments. This substantially increases the workload for industry and regulators without increasing the safety of products on the market. This can potentially impact the introduction of new AS in the EU, without increasing the safety of products that are currently placed on the market.

Benefits:

Reduced cost to companies since fewer substances would be subject to frequent review. A more manageable system for MS and companies focussed on fewer substances. Only a very small number are likely to be substituted anyway since there are now few realistic alternatives for many situations.

Costs

Possible cost of adverse impacts if certain substances not substituted due to narrow selection criteria.

Minor administrative cost to MS/COM of setting the criteria; editing and communicating a guidance document. But such costs likely to be similar whatever the criteria set.


The evaluation of this option requires data on the administrative costs as well as on the costs imposed on the industry and authorities under the current regulation. These would need to be compared to the respective costs (or benefits) imposed by the alternative approaches. A precise evaluation of cost saving for PPP will depend on how precisely the criteria are defined.

Implementation feasibility

A process could be developed which allows substituted uses to be quickly re-authorised when conditions leading to the substitution have changed.

Criteria should be carefully defined so that scientifically robust principles are applied in the assessment of PBT (persistent, bioaccumulative and






toxic) properties.

Alternatively the Stepwise approach developed by ECPA could be taken into account. Stepwise is a process which allows stopping the process as soon as one condition for substitution is not fulfilled.

3 Purpose of the Regulation in terms of protection goals

Art 1 Revision

Protection goals should be more specific. Preventing adverse effects on biodiversity and ecosystems services should clearly defined as a part of these goals.

Rationale

In the current Regulation, the protection goals are too vague.

Benefits

Would reduce uncertainty in the legislation’s interpretation for PPP manufacturers and help them in developing less impacting products in the future

Reduce R&D costs with more focused testing

Possibly reducing vertebrate use in toxicology

Would be costs or benefits to crop protection companies depending on the particular goals selected relative to the current position

Costs

Working group and expert consultation to define more specific goals ; cost of updating the goals following the scientific progress; cost of elaborating and editing of the guidance


A quantitative evaluation would be very difficult; however, some qualitative aspects could be identified in relation to the benefits of establishing a set of indicators to monitor the effectiveness of the regulation.


Specific quantitative indices of animal and plant species (e.g. the Shannon Index ) could be used and a specific guidance could be provided

4 Periodic review of data requirements and other developments

- Revision

All significant technical developments to data

requirements and guidance to be introduced in batches

rather than separately

Rationale:

The EU pesticide regime has been in a constant state of

technical development since its inception. The need to keep

abreast of up-to-date science is clearly important but it is

difficult to accommodate constant change within the review

and re-registration system established by Regulation

1107/2009. Some improvements in this respect have been

made but there remains an argument for technical changes

to be batched together and introduced such as at the

Benefits:

This would make the system:

more efficient and more manageable reducing costs for companies and for MS;

easier to evaluate its performance in terms of public health protection

Costs

Possible cost of adverse impacts between updates.


This aspect cannot be evaluated quantitatively but its significance could be highlighted through specific examples of administrative costs and other associated difficulties that such constant changes impose.

Difficult to evaluate the cost of any impacts occurring between periodic updates


Changes could be made more frequently if there were a pressing safety concern. However, very few developments fall into this category.






beginning and mid-point of each review cycle.

5 Data requirements (methodological aspects)

Art 8 and 33 and Annex II; Art 67-2

Revision

Monitoring needs should be clarified (Art. 67-2)

A sensitivity analysis to identify key species and areas of the environment to be monitored could be introduced.

The data call-in requirement issued by the US EPA could be considered as a good practice.

Integrated use of human, experimental (both in vivo and in vitro) and computational data to limit animal testing could be promoted.

Actual exposure should be taken into account, rather than the compilation of worst-case exposure assumptions.

Omit repetition of residue data if use pattern reduced;

A risk/benefit evaluation (including socio-economic criteria) should be included in the decision making process.

Rationale:

This option covers several aspects related to the data requirements and specifically to the guidance developed under Regulation 1107/2009. There are several areas of the current procedure that could be modified to increase the efficiency of the process. Much of the required data is found as unnecessary and could be removed to reduce costs without jeopardising the effectiveness of the Regulation.

Benefits

Reduce R&D costs with more focused testing


Costs

Administrative costs to MS/COM in defining more specific monitoring needs (linked with protection goals) and developing and agreeing new methodological approaches


The evaluation of the effectiveness of the various components would require input from different experts. Overall cost savings would be difficult to be estimated but this aspect could be addressed through illustrative examples.

This would require data on costs which are borne by both the authorities and the industry.


Adapted R&D strategy would need to be developed – no major issues.

6 Data requirements (nature of data)

Art 7, Art 8, Art 76, Art. 62 More linked - Regulations 544 and 545/2011.

Revision

The assessment could focus on the active substances. The commercial preparations could be tackled at the request of the competent authority in the MS.

Possibility to omit the following tests ):

metabolism, distribution and expression of residues in fish;

feeding studies in fish;

rotational crops residues (second tier);

Benefits

Reduce R&D costs with less but more focused testing


Costs

Possible increased human health and environmental impacts

Administrative costs to MS/EU in updating data requirements

Cost-benefit evaluation feasibility

Benefits in terms of reduced R&D costs to companies could be quantified. Potential costs in terms of any future adverse impacts remaining unnoticed through lack of data not quantifiable..


Adapted R&D strategy would need to be developed – no major issues.

An alternative to ADME data would be for the data to






aerobic mineralisation in surface water;

18 month-mouse carcinogenicity study;

The soil trigger, of DT50lab ≥ 60 d, for the requirement of field studies could be removed and applicants allowed to decide if field studies are required to refine the risk assessment.

The HPLC method for Koc determination could be allowed and QSARs permitted where the calculator has been shown to be relevant for the type of compound being applied for.

Only require water/ sediment studies at a higher tier if an assumed worst case DT50 of 1000days does not show an acceptable risk

Residue data and efficacy data for minor uses;

Efficacy data when a new formulation containing an old active substance is presented, for which no new rates or claims are put forward;

anaerobic soil degradation study;

aqueous photolysis and quantum yield studies;

reduce requirements related to water sediment studies;

the soil trigger, of DT50lab ≥ 60 d;

the ready biodegradation study;

Sewage Treatment Process studies for agricultural use;.

For surface water and sediment risk assessments the use of simple first tier calculations for spray drift and drain flow at the first tier could be allowed. FOCUS Surface Water modelling would only be required as a higher tier refinement. Experimental evidence across Europe supports this approach.

A lot of expensive kinetic Absorption, Distribution, Metabolism and Excretion (ADME) data is generated but the majority is not used by regulatory authorities.

Rationale

Experience suggests that a lot of data is required which rarely, if ever, drives the risk assessment. It is thus

be triggered only where an issue arose from other studies that it would help to resolve.






disproportionate since it has very little influence on the regulatory outcome.

7 Environmental data requirements based on scale of use

As above Revision

The approach would follow that within REACH; data requirements being triggered by scale of use. For example data might only be required for products that would be used on say over 5% of agriculture land within a Member State.

Rationale

Currently an unacceptable risk which occurred in only 10% of a major crop grown on 80% of the agriculture land would probably be accepted. But an unacceptable risk occurring in 100% of a minor crop grown on 5% of the land would not.

The principle that minor uses require less data is already accepted for plant protection products in that only 4 residues trials are required for minor crops against 8 for major crops.

Benefits

Would decrease costs to companies in data generation and potentially result in more product authorisations particularly for minor crops benefitting growers.

Costs

Would be some increase in environmental impacts though these should be relatively minor relative to those already tolerated


Broad benefits/costs might be established by examining specific cases where approvals previously refused could be granted


The approach, though based on REACH, is conceptually quite different to that currently followed for plant protection products. The details would require further examination.

8 Data requirements for impurities and metabolites

As above Revision

A lot of time and effort is spent generating and assessing toxicity data on impurities within the agreed specification. Many are highly unlikely to affect the overall assessment.

A lot of time and effort is also spent on assessing metabolites in plants and in the environment which again hardly ever drive the risk assessment.

Rationale

For instance a plant metabolite present at 6% of the level of the parent compound is unlikely to be an issue for an active substance with an ADI of 0.01mg/kg bw.

QSARs could be used on a case by case basis, to support the toxicological evidence in these sorts of cases.

For environmental metabolites a tiered approach could be taken. If the basic acute ecotoxicology tests (fish, daphnia

Benefits

Savings to companies in data generation and to Member States in evaluating studies

Costs

Possible increased human health or environmental impacts if impurities/metabolites not fully assessed though experience suggests these likely to be minimal


Broad benefits/costs could be assessed by examining specific cases.


Would require a fundamental change in the current approach. The details would require further examination






algae) and in vitro genotoxity tests do not indicate the metabolite is more toxic than the parent, further data requirements and a risk assessment would not be required. Alternatively QSAR could be used to predict if metabolites are more toxic than the parent – if they are not, they would be excluded.

9 Data requirements and data evaluation-Assessment factors

As above and Uniform Principles

Revision

Currently in biocide risk assessments, assessment factors (AFs) for ecotoxicological end-points used are substantially based upon the amount of data and study type (s) that are available. Therefore, it is possible to display an acceptable risk based upon a small data set if the calculated RAC (regulatory acceptable concentration) is sufficiently high. Additional study data can significantly reduce the AF (again, dependent upon the study type and amount of data) since the uncertainty of the toxicity to different organisms is reduced.

Rationale

A similar scheme could be adopted for pesticide risk assessments. This would allow the standard, first-tier, data set to be reduced where the ecotoxicity of a compound is clearly very low.

Benefits

Savings to companies in data generation and to Member States in evaluation time.

Costs

Risk of increased environmental impact due to less data being available likely to be minimal


Benefits of reduced data requirements could be quantified. Costs likely to be minimal


Principle already accepted for biocides. The details would require further examination.

10 Authorisation process: zonal approach

Art 7, 33 & 38

Revision

Transparency in the selection of the Zone Rapporteur MS should be improved.

The mutual recognition between MS should be compulsory (the term ‘may’ is used) .

Rationale

This option would ensure that duplication of work and the administrative burden for industry are avoided. In addition, common mitigation tools across MSs could allow a more harmonised approach in the evaluation and authorisation

Benefits

Would decrease costs of authorisation processes for PPP manufacturers and have a positive impact on sales

Would decrease administrative costs for MS.

Could increase the number of PPPs available in some MS, which could be advantageous for PPP users

Costs

Potentially higher environmental impacts in individual


Specific cases in which the mutual recognition was not applied need to be identified, including the associated costs . Based on these cases the additional costs for companies could be roughly estimated.

A quantitative (or semi-quantitative) evaluation could also be conducted based on administrative costs for MS.


Implementation requires MS to be willing to take a






process. These aspects are already put forward under the current regulation but are not compulsory.

The current zonal process is regarded as complex and the selection of Zone Rapporteur Member is non transparent. In addition some Rapporteur MS do not have sufficient means to evaluate the zonal dossiers.

Currently there is a large number of national requirements, many of which are in place due to historical practices and a lack of harmonisation between MSs

According the conclusions of a survey on competent authorities the most efficient Competent Authorities were those who operate in a centralised fashion. A key aspect is that competent authorities have high autonomy in its tasks execution and this should not be confused with legislative development.

Under the option of centralisation, the mutual recognition would no longer be required.

MS if their standards ‘higher’ than the zonal approach agreed.

Benefits and costs could vary depending on how the agreed zonal ‘standard’ compared with that of the individual MS.

harmonised zonal approach

11 Tests on vertebrate animals – data requirements

Art 7 and 8

Revision

For tests related to acute toxicological effects, the use of laboratory animals could be reduced significantly by adopting the revised testing scheme advocated by ILSI/HESI (International Life Sciences Institute - Health and Environmental Sciences Institute).

Rationale

The potential reduction in the use of laboratory animals would reduce the associated costs as well as issues related to data sharing requirements in such tests.

Benefits

Savings to companies through reduced data requirements

Animal welfare benefits through reduced testing.

Costs

Minimal. This option does not compromise the assessment of the critical endpoints in the human risk assessment, it avoids the production of unnecessary data.


Estimates on the costs of such tests. Qualitative aspects related to data sharing (e.g., difficulties associated with the cost sharing) would need to be evaluated.


Revision of data requirements would be required

12 Requirements on efficacy

Annex II, point 3.2

Revision

Requirements on efficacy data (currently based on the ‘uniform principles’) should be removed and replaced by an approach similar to the US approach (‘let the market decide’).

Rationale

Such approach allows the evaluation of efficacy based on

Benefits

Would decrease costs of authorisation processes for PPP manufacturers.

Costs

Possible costs of environmental and health damages caused by the introduction of new PPPs whose efficacy has not been demonstrated upstream of their


The evaluation would be based on a comparison with the US approach but this might not be always simple to do due to the incomparability of data due to several differences that exist between these two systems. Estimates on the costs of such tests need to be done. Qualitative aspects related to data sharing (e.g., difficulties associated to the cost sharing) would






real – life conditions in which certain specificities could be taken into account.

placing on the market.

Risk of increased doses (as data on ‘minimum effective dose’ no longer applied) and hence increased risk to human health and the environment

Would become more difficult to manage emergence of resistance

need to be evaluated as well.

.

13 Criteria to assess risks to groundwater -

Art 4 and 29

The criterion used to assess risks to groundwater should be reviewed, as the current threshold (0.1 µg/L) seems unreasonably precautionary.

Limit concentrations could be rather based on a risk approach and/or the WHO safety guidelines.

Rationale

The current 0.1ug/L limit is an arbitrary value substantially below that required for human health or environmental protection for the great majority of pesticides in current use.

Examples exist where substances have been restricted because the models show that the substance is likely to be found in ground water above 0.1ug/L - but a consumer risk assessment for drinking water would indicate that the risk is acceptable at the modelled concentrations

Benefits

Reduced costs to companies and to growers as more products would pass the groundwater assessment

Costs

Potential for higher costs for Water Companies for treatment to meet Drinking Water Limit standard.

Potentially increased monitoring costs for companies in some cases.

Small increase in costs for companies and MS in submitting/undertaking risk assessment

Should be no significant adverse human health or environmental impacts provided risk-based approach backed up by monitoring is robust.


The evaluation of this option would require data on the number of AS which have not been authorised due to this limit. Additional costs occurred to make AS compatible with the limit value would also need to be acquired. Such data is very difficult (if not impossible) to acquire.


Limit is a long-established feature of the EU plant protection product regime. Its removal would be controversial.

14 Biological substances and biopesticides

Art 77 Revision

Data requirements and guidance for biological substances/biopesticides should be reviewed and developed.

Rationale

According to stakeholders the current data requirements and the lack of adequate guidance creates a barrier to registrations. There are also cases of contradictions in the legislation (e.g. depending if the same substances are used as pesticides or in other uses).

Benefits

Would decrease costs of authorisation processes for manufacturers of Biological substances and biopesticides and improve product availability for growers.

Would decrease uncertainty in regulatory outcome.

Costs

Administrative costs in developing current data requirements and guidance


A quantitative evaluation would be possible if relevant market data can be provided by companies which produce biological substance and biopesticides.


Biological substances/biopesticides can vary widely in nature so providing clarity and consistency in approach may be difficult.






15 Data protection Art 59 Revision

Regulatory Authorities could withdraw from this role and leave data protection to commercial negotiation and the courts.

Rationale

From a regulatory perspective MSs are only concerned that there are relevant data supporting a use or product. Ownership is a commercial matter with any dispute could be sorted out through the courts. Companies can exploit the system by generating data simply to prevent other companies gaining access to products, thereby reducing competition in the market.

Benefits

Avoid duplication of effort to generate data

Could reduce costs for MS authorities which currently deal with data protection aspects

Costs

Court and other relevant costs might occur for resolving possible disputes between companies


The evaluation of this option would need to be based on a comparison of the administrative costs which are currently borne by the MS authorities and the costs which would occur if data protection issues would be resolved in courts or through negotiations. Such an evaluation would be difficult and the results rather theoretical.


There is already a model for this approach in Article 62.6 on access to vertebrate studies.

Alternatively the data protection model of REACH could be followed in order to ensure legislative coherence in the EU.

Expert opinions on the policy options


Chapter 4: Expert opinions on the policy options

his chapter presents a brief summary of the feedback received by the experts invited to

comment on the axes of simplification which were described in the previous Chapter (Chapter

3: The group of experts was established in co-operation with Defra (for the list of experts see

ANNEX D: List of stakeholders and experts contacted. The experts were also asked to provide

information and sources, for the calculation of costs.

4.1 Overview of expert opinions

In the overview provided in this section, each option corresponds to a respective axe of simplification

identified inChapter 3:

4.1.1 Option 1- Cut-off criteria – risk based versus hazard based

Overall, there is a broad consensus that the risk-based approach is a more appropriate approach as it

entails several benefits for the industry without increasing significantly the environmental risks. An

aspect to be considered when a risk based approach is chosen versus an hazard based one is that a

risk-based approach is substance- and use-specific and therefore considerably more demanding in

terms of the required data on sources, pathways and receptors for each examined substance. For this

reason, although the risk-based method is preferred, if followed properly it would not simplify the

overall procedure, which is laid out by the current regulation. Moreover, an expert argued that, in

certain situations, under a hazard-based approach the industry revenue might be actually higher

compared to the revenues that would be created under a risk-based approach. For example, such an

increase could be achieved if alternative AS is more expensive or used more frequently. In order to

perform a detailed cost estimation for this option, it was suggested that it would be useful to develop

case studies. This approach would enable a better understanding of the environmental impacts under

the different scenarios.

4.1.2 Option 2- Comparative assessment and substitution criteria

Overall the experts agreed that currently there is a large number of AS which may be classified as

candidates for substitution and that this may lead to an excessive number of comparative

assessments. The list of candidates of substitutions is seen as highly vulnerable to misinterpretation

and misuse.

The best option to know what exactly corresponds ‘significant’ proportion of substances to be

considered as candidates for substitution is considered to be applying the output of a risk assessment.

For this reasons experts consider that predefining the proportion (e.g. 10 or 20%) is not applicable.

An expert from the industry argued that the comparative assessment, the substitution of uses and the

establishment of a list of candidates for substitution are provisions that do not add value to the whole

T



process since a risk-based process in the authorisation of AS and PPPs is robust enough to ensure that

the authorised pesticides are safe. Accordingly to ECPA and Dupont, a negative commercial impact is

caused when a substance is 'blacklisted' as a candidate for substitution.

4.1.3 Option 3- Purpose of protection goals

A better definition of protection goals should help in prioritising both health and environmental

aspects. Specifically on the environmental protection goals, these should not include only the direct

benefits people gain from them (i.e. derived from ecosystem services) but also the structural and

intrinsic functional characteristics of the ecosystems in order to take into account the indirect, the

long-term and subtle environmental effects. The large majority of the new requirements and

guidance documents are not based on the possible adverse effects, which have been identified, but

instead they are driven by a demand to reach a greater certainty on observed effects. Despite the

possible costs required for acquiring the necessary knowledge for setting more specific protection

goals, the benefits are multi-faceted and difficult to evaluate since our knowledge on ecosystem

services is not exhaustive.

4.1.4 Option 4- Periodic review of data requirements and other

developments

Overall, the option of updating data requirements and guidance according to new technical

developments periodically and in batches (rather than separately), is recommended. However, it is

argued that in cases of genuine adverse impacts, it should be accepted that these issues would need

to be dealt with more urgently. Targeted interviews with regulators and/or industry could help in

understanding how to deal with such an updating.

4.1.5 Option 5- Data requirements (methodological aspects)

Accordingly to experts, monitoring needs need to be clarified and prioritised and should consider the

possibility to have chemicals with synergistic effects and the long-term effects low concentrations

exposure. An expert pointed out that the use of Species Sensitivity Distribution analysis could provide

a good theoretical background for prioritisation indicating the proportional benefits able to be

introduced with the least restrictive regimes.

4.1.6 Option 6- Data requirements (nature of data)

One expert argued that the tests that the stakeholders proposed to be removed from the current

regulatory regime are important in the assessment process. Given the great complexity of natural

processes and interactions in ecosystems that are still largely not fully understood, these tests help in

orienting a diagnosis of environmental problems. Specifically, a large amount of this evidence is very

important to enable sound environmental management and decision-making. Even in cases where

the data is not used in the assessment itself, the tests play an important role in the decision-making



process, the development of comparative assessments and more largely the safeguarding of public

safety. It was also argued that the proposed revision oversimplifies the assessment of PPPs. In this

context, the removal of a required test cannot be justified solely on its inconvenience. Under the

polluter-pays principle, the cost of conducting these detailed and demanding tests should be borne by

the manufacturers of PPPs. If the obligation of the manufacturers to carry them out is removed, there

will be a lack of useful data unless this responsibility is shifted to another actor (e.g. a public

authority), which is a debatable approach. This indicates that if this option is recommended in the

future, most likely it will be strongly opposed by NGOs and CAs.

4.1.7 Option 7- Environmental data requirements (scale of use)

Accordingly to experts, if environmental data is prioritised on the basis of more frequently used

products, this might potentially impose great risks. As already pointed out, the data requirements

should be rather defined by the establishment of a risk-based assessment process, which will

integrate the emissions estimation anyway. A detailed risk assessment will present exposure

scenarios integrating information on product consumption levels by key user groups, or the scale of

use in sensitive or unique areas. For example if a crop represents a high proportion of the intake in a

specific group of individuals (e.g. crops that are consumed and produced locally, used in the

production of baby food, or used in an environment under pressure) then a small-scale use would not

necessary implies that there is a limited risk to individuals or the local ecosystems.

Another expert commented that the required environmental data should be evaluated based

primarily on the identification of the provided ecosystem services and the setting of common

protection goals among MS. This would lead to a greater harmonisation in the authorisation

decisions.

4.1.8 Option 8- Data requirements for impurities and metabolites

This option is difficult to implement because of currently lack of data on impurities and metabolites,

and that the cost of producing these data. However, modelling (QSARs) could be used on a case-by-

case basis, to support the toxicological evidence. This approach would permit to reduce costs and at

the same time ameliorate the overall assessment.

4.1.9 Option 9-Data requirements and data evaluation – assessment

factors

No expert opinion on this aspect

4.1.10 Option 10- Authorisation process: zonal approach

The current zonal process is complex and the selection of Zone Rapporteur Member State non –

transparent. Experts support the establishment of a harmonised approach, across all MS.



4.1.11 Option 11- Tests on vertebrate animals in data requirements

Exposure to pesticides is mainly related to chronic effects and to a lesser extent to acute effects.

Chronic effects might be tested with protocols using fewer animals than acute ones. For this reason,

the option to reduce the number of animals can be considered as highly beneficial for both the

industry and aspects related to animal welfare.

4.1.12 Option 12- Requirements on efficacy

It was argued that letting the market decide on the efficacy requirements, as proposed by industrial

stakeholders, is not a sound approach. This might lead to increased risks since the process would be

exposed to too many commercial pressures, which are independent of the nature and the quality of

the product but rather derived from advertising and agreements strategies between companies.

4.1.13 Option 13- Criteria to assess risks to groundwater

According to academic experts, the criterion used to assess risks to groundwater cannot be

considered as simply precautionary when multiple pollutants are considered. Several studies

demonstrate the opposite in terms of chronic, endocrine and sub-lethal effects. It was then argued

that the limit should be actually set at higher levels. The presence of a substance, whatever the

concentration is, indicates a pathway and the possibility for bioaccumulation and human exposure

and is an important piece of information on pollution pathways which potentially concern also other

non-considered contaminants.

The industrial stakeholders do not share this vision. They state that even if the concentration level in

groundwater exceeds the limit of 0.1 µg/L the concentration in drinking water are normally at

acceptable levels.

4.1.14 Option 14- Biological substances and biopesticides

An expert agreed with the stakeholders’ opinion that a contradiction exists in the legislation

concerning multiple uses of the same substance under different legislative frameworks requiring more

or less stringent criteria for the environmental and health impact assessment. The development of

separate data requirements and guidance thus would certainly facilitate the authorisation of certain

products (i.e. biopesticides), but also create significant administrative costs.

4.1.15 Option 15- Data protection

It was argued that the current regime in which the responsibility for data protection falls on the

regulatory authorities, allows greater transparency and much needed accessibility to data on safety. It

was also commented that the development of new knowledge needs could then be easily based on

previously produced data, which are also verified by quality control procedures. Experts consider that

it is not a good option to leave data protection to the private sector. Moreover, the revision of this



option will favour the major data holders against the smaller generic companies. However, some

intermediate solutions exist where, like in the United States, the procedure minimises authorities’

involvement.

4.1.16 General comments on the rationale behind the choice of options

An expert argued that many of the proposed actions of simplification are recommended in order to

reduce the difficulties and the associated costs. In the current context of great uncertainty on the

impacts of chemicals in the environment and on the effects of their interactions, an oversimplification

might be deleterious since the use of precaution is normally increased as the available data reduces. A

well-informed simplification of the procedures would impose excessive requirements of data, which

are currently unavailable. In this context, the whole recommended approach rather than the specific

axes of simplification is seen as unrealistic.

Another expert insists on the fact that efforts should be made to ensure that targets of the regulation

are clear, harmonised and supported by peer-reviewed science. If hard evidence is not available

targets should be based on a balance between precaution and the cost of compliance.

4.1.17 General comments on the feasibility of cost-benefit evaluation

In this context, a cost-benefit analysis should be more holistic and evaluate all benefits and costs to

society in order to provide subjective and robust results. However, a cost benefit analysis is best

carried out at the level of a crop or a pest and that should be carried out specifically for a MS. This

makes the feasibility of the cost benefit evaluations problematic since it is doubtful if sufficient data

exists to make robust assessments. The analysis should indeed try to help to weight the costs of

compliance against the environmental, health, economic and social costs.

Cost estimates of policy options





Chapter 5: Cost estimates of policy options

This chapter provide a rough estimate of the costs of each policy option. The cost estimates are

based on assumptions as detailed in the table below (Table 2).

Table 2: Estimated costs of the simplification options

Option No.

Targeted legal requirement

Ref. Estimated costs and assumptions

1 Cut-off criteria – risk based versus hazard based

Annex II, points 3.6 & 3.7, others?

Estimated saving: 415-820 M € (conservative estimate) Assumptions: Recent studies published by the WRc and Fera in the UK put the potential costs of the endocrine disrupter criteria alone of between £225 and £440M at least depending on the definition of an ED. This takes into account only the 276 substances active in the UK market today. Applying a scaling factor of ca. 1.5 to account for the overall number of actives in the EU (432), this would bring the total saving to the farming industry from removing cut-off criteria and moving towards a risk-based, rather than hazard-based safety assessment process to 415-820 M€. The impact on crop protection companies is less certain. There will be lost sales of products based on excluded substances but these may be partially offset by new markets for alternative (but less efficacious) products where this is possible. There may be some reduction in data generation in the long-term a if fewer actives are approved but initially data have to be provided whether cut-off criteria exist or not. If a substance is lost then data will be required to establish new uses of alternatives. Overall savings rather than costs for crop protection companies are expected from the removal of the cut-off criteria but these seem likely to be considerably less than the potential savings for farmers. The proper inclusion of exposure information in the overall PPP safety assessment could result in gains to industry from keeping AS in the market, which otherwise might have to be withdrawn based only on hazard-based criteria. Clearly, the exact number of AS that would benefit from this change, would depend on the precise way of treating exposure in the revised Regulation; in particular, it would depend on the exposure-based criteria for waiving toxicity testing for data generation. This, on the other hand, would entail a significant change in the way exposure is being reckoned to date in order to fill the current gaps with robust estimates coupling monitoring and computer simulation/modelling exposure through different environmental media and pathways.

2 Comparative assessment and substitution criteria

Art 24 & 50 & 80.7 Annex II, point 4

Estimated saving: 10-100 M € Estimated cost: 2.5-5 M € Assumptions: The administrative cost will be relatively small but not insignificant. The Commission has recently indicated that around 30% of substances could be candidates for substitution. Based on current assumptions (extrapolated to each Member State) this could involve 50-100 staff years of additional effort across the EU involving costs of say 2.5-5 M €. We would expect these costs to be replicated in companies who we anticipate will have to include information relevant to comparative assessment with their applications. With regard to industry, there will be winners and losers in this respect making the impact difficult to estimate. The final outcome will depend on the position in relation to alternatives in individual Member States. If alternatives are available the impact on farmers should be small and whilst some companies may lose out on sales through substitution others should gain. There does seem likely to be a negative commercial impact on those substances. A negative commercial impact is caused, however, by putting an AS on the candidate for substitution list. This would, on the other hand, spur innovation in the PPP manufacturer industry, making the overall financial estimate complicated. Overall, the positive impact (saving) on industry and the Member States from removing this provision is estimated to lie between 10 and 100 M €.

3 Purpose of the Regulation in terms of

Art 1 Estimated savings: Variable up to 38 b € Assumptions:



Option No.



protection goals For industry a streamlining and refinement of the protection goals set by the legislation resulting in better specifying these goals bears the potential for significant benefits. Out of the 432 AS in the market currently, 130 could fall into one of the main five toxicity categories (carcinogens, endocrine disruptors, reproductive and developmental toxicants, acute toxicants) based on the current Regulation scope. This characterization could mean that these substances would have to be taken out of the market. Considering that the latest estimate of the expenditure necessary for the discovery and development of a new PPP amounts to 290 M €, the total loss of industrial investment if these 130 substances were to be withdrawn from the market would rise to 38 b €. Additional costs relate to the loss of plant protection and the probable increase in the use of other substances acting as alternatives, albeit affected by other hazard based criteria. Thus, re-consideration of the protection goals of the Regulation overall to reduce uncertainty in the interpretation of the Regulation by PPP manufacturers would reduce R&D costs with more focused testing and limited use of vertebrates in toxicological testing. The overall amount of the respective savings can only be estimated in detail once the regulatory protection goals are re-set. From the point of view of the regulators, the change considered herein amounts to the only minimal administrative cost associated with the revision of the protection goals. Only expert meetings and comitology are needed for that – the cost may thus be contained.

4 Periodic review of data requirements and other developments

- Estimated savings: 130-135 M € Assumptions: The timing of the review is implemented at the review stage; thus the companies would know when this was supposed to be and a more streamlined and improved process would result for both regulators and data providers. Considering that over the last fifteen years 5-8 new AS appear annually and assuming that the review period would be ca. 5-10 years this would mean that new data requirements and other developments based on technical progress and new scientific knowledge on the environmental and human health implications of the use of these AS would regard 25-40 AS at the most. The cost to industry for the AS dossier preparation amounts on the average to ca. 550 k€ per substance. Thus, the overall cost for completing and revising the dossier for these substances would amount to 14-20 M €. On the contrary, if the review was more often and not synchronized for all substances concerned, this cost could rise to 150 M €. In conclusion, the synchronized and pre-determined review plan would result in 130 – 135 M € of savings to industry and to regulators. Clearly, this plan should allow for exceptions in the case of the delivery of very significant information that would very importantly change the outcome of the risk assessment process for the specific substance.

5 Data requirements (methodological aspects)

Art 8 and 33 and Annex II; Art 67-2

Estimated savings to industry and authorities: 45-46 M € Assumptions: The testing costs would be expected to be reduced by ca. 20% for each active substance on the basis of a detailed analysis of the current methodological requirements with regard to testing. Considering the testing cost savings for the total number of 432 AS currently in the market the total savings amount to 47 million €. For regulators, the envisaged simplification amounts to only meeting costs and financing specialised studies. The overall cost estimate for these is ca. 1 M € (perhaps slightly higher than that, but not significantly so).

6 Data requirements (nature of data)

Art 7, Art 8, Art 76, Art. 62 More linked - Regulations 544 and 545/2011.

Estimated savings: 70 M € Estimated cost: 1 M € Assumptions: The testing simplifications and targeting that is envisaged in this simplification intervention would result in a reduction of 30% in terms of the overall testing costs when considering the array of tests that would be involved. This means a reduction of the data generation cost to 165 k€ per AS. This could be applied to the 432 AS in the market resulting in an overall estimate for savings to industry in the order of 70 M €. The main actual cost for regulators is the administrative cost to set up the revised (more targeted) data requirements. This would not exceed 1 M €. I do not anticipate any adverse health impacts from the more targeted data requirements, since the objective of this change in the Regulation is not to reduce the level of protection of man and the environment; on the contrary, the objective here is to streamline the process and make the protection more focused and thus



Option No.



the whole system more cost-efficient. Thus, I do not expect any additional cost coming from the monetary valuation of public health impacts.

7 Environmental data requirements based on scale of use

As above Estimated savings: 40-47 M € Estimated cost: 1-10 M € Assumptions: Based on the current profile of PPP use in the EU, this simplification could result in a reduction of data generation cost on the order of 15-20%. This means a reduction of about 40-47 M € for the 432 AS in the market. The cost of implementation would be reduced for industry in comparison to the current Regulation. However, the cost of the probably higher environmental impacts needs to be accounted for. Given the uncertainty associated with this type of calculation (both with regard to impact and the associated monetary cost of environmental degradation and loss of ecosystem function) a moderate cost on the order of 1-10 M € has been reckoned here. This is based on previous experience from projects estimating the monetary cost of adverse impacts (attributed to increased environmental contamination with chemicals). Thus, overall a net benefit (saving) on the order of 15-20 M € would be expected. If the estimated environmental impacts are not irreversible, this is an option that is worth considering. A regional (zonal) approach could be applied herein, in order to make sure that the residual impacts on environmental function are manageable.

8 Data requirements for impurities and metabolites

As above Estimated saving: 47 M € Assumptions: The data generation simplification considered herein would result in ca. 20% reduction in overall testing costs at least. This means a cost saving of ca. 47 M € for the 432 AS in the market. The respective monetary cost of adverse impacts is reckoned as minimal in accordance with the estimated level of adverse environmental and health impacts, which are deemed to be minimal.

9 Data requirements and data evaluation-Assessment factors

As above and Uniform Principles

Estimated saving: 20 M € Assumptions: The savings to industry in data generation and to Member States in evaluation time amount to ca. 10% reduction of the overall cost for the generation of the data necessary for the first-tier ecotoxicity evaluation. This means a reduction of ca. 50 k€ per AS, i.e. an overall saving on the order of 20 M €. The estimated cost due to the minimal adverse environmental impacts is outweighed by the anticipated savings in data generation and in the time needed for dossier evaluation.

10 Authorisation process: zonal approach

Art 7, 33 & 38 Estimated saving: 32-34 M € Assumptions: The additional administrative burden (survey cost, etc.) would imply an increased administrative cost. This would be offset by the reduction in national requirements and the abolishment of the mutual recognition process (since the latter would be automatic). Thus, the final net cost would be on the order of 10.5-12.5 M € depending on the level and speed of implementation, which in turn would depend on the degree of preparedness encountered in the public administration of the different Member States. At the same time, the corresponding cost reduction to industry is estimated to ca. 10%, i.e. ca. 50 k€ per AS. This is translated into 21.5 M € for all the 432 substances in the market. Thus, the overall system change (simplification) would be expected to result in a net saving (for both industry and MS competent authorities) of 32 to 34 M €.

11 Tests on vertebrate animals – data requirements

Art 7 and 8 Estimated saving: 34-110 M € Assumptions: A 15-50% reduction in data generation cost is estimated on the basis of experience from REACH and a careful consideration of the toxicological testing costs with respect to the overall cost of registration and testing an active substance. This means a 34-110 M € reduction for all the 432 AS in the market. The large variability in the estimate is introduced in order to account for differences in testing requirements for PPPs The only foreseeable cost is the administrative cost for the establishment of the reduced testing requirements. This is only minimal in comparison with the very significant savings for industry. Thus, the net cost is close to null.



Option No.



12 Requirements on efficacy

Annex II, point 3.2

Estimated cost: 10-100 M € Estimated savings to industry: 47 M € Assumptions: This simplification would result in a significantly reduced number of field trials for each AS; this would mean a considerable decrease in the overall cost of data generation required for AS registration and authorisation. Currently field trials amount to more than 20% of the overall cost of putting a new AS in the market. Not all field trials are used for efficacy testing; yet, the overall reduction in cost to industry would amount to ca. 47 M €. The monetary cost of the potential adverse environmental and health impacts can vary from moderate to high given the large number of existing and new active substances. The calculation is based on previous studies of monetary valuation of adverse environmental and health impacts attributed to chemical contamination of environmental matrices and the result of a recent (soon to be published) study on the health impact of plant protection products in the EU-27. However, extensive health and environmental safety data would still be required. It may be the case that, given that data would no longer be required on the minimum effective dose, some treatment rates might increase though these would still have to remain ‘safe’. Given this it could be expected that the estimated costs would be towards the lower half of the cost range estimated above. Overall, this simplification bears a lot of potential for significantly increasing the cost-efficiency of the overall PPP regulation in the EU. Nevertheless, given the potentially high adverse environmental health impact a more detailed feasibility study should be undertaken before making a well-informed decision on this. Experience from the corresponding US system should be taken into account and detailed estimation of the avoided testing costs needs to be undertaken in close co-operation with industrial stakeholders. Data sharing options need to be considered as well in order to increase the cost-efficiency of the overall simplification analysed herein.

13 Criteria to assess risks to groundwater

Art 4 and 29 Estimated saving: 23.5 M € Estimated cost: 10-100 M € Assumptions: This change would result in a decrease of ca. 10% in overall ecotoxicological testing and environmental sampling and modelling cost. This translates into ca. 23.5 M € of savings to industry and farmers/growers for all the 432 AS in the market. However, this simplification bears a high probability of increased cost to water companies for water treatment in order to reach drinking water limits and monitoring water quality. In addition, industry and competent authorities alike may have to bear a higher risk assessment cost during substance registration. No significant adverse human health effect is contemplated herein as long as the overall risk assessment process is robust and adequate groundwater monitoring backs it up.

14 Biological substances and biopesticides

Art 77 Estimated savings: 22-23.5 M € Estimated cost: ≤1 M € Assumptions: The administrative cost for the establishment of the data requirements and guidance is offset significantly by the decreased cost of authorisation for industry and the reduced uncertainty in regulatory decisions. Thus, the net cost is considered minimal. Relevant market data need to be provided by industry so as to perform a robust quantitative evaluation of potential savings to industry in terms of registration costs. Nonetheless, based on current experience the change considered herein would be expected to involve ca. 10% of substances, resulting in a reduction of cost of the order of 22-23.5 M € from avoided authorisation costs. Thus, an overall saving of 21-22 M € is reckoned in the overall system.

15 Data protection Art 59 Estimated cost: 10-100 M € Assumptions: Cost of litigation regarding proprietary information and patents can be exorbitant. Given the large number of substances involved, this cost is set to the maximum category. In reality, there is no limit to the actual cost. Clearly, allowing the market regulate data protection issues and the related costs is the most cost-efficient way of ensuring data sharing without promoting unfair competitive advantage to companies that use already derived original information/data. However, the overall actual efficiency of the system cannot be



Option No.



fully quantified and thus the accompanying savings cannot be reliably estimated without getting some information from industry on the actual costs and financial loss induced by potentially reducing the competitive advantage of companies bringing into the market new plant protection products.

Conclusions and recommendations


Chapter 6: Conclusions and recommendations

The main policy options considered in this report target:

the introduction of new cut-off criteria for plant protection product active

substances replacing the current hazard-based approach with a risk-based one and

the introduction of criteria for substitution based on comparative assessment

among possible substitute substances;

the scope of the Regulation in terms of protection goals and its implementation;

data requirements promoting a more flexible and cost-effective implementation of

the Regulation, including a move towards more integrated testing needs and the

possibility of using extensively novel approaches to data collection including the

TTC approach, read-across and computational tools such as QSARs and PBPK

models for active substance and metabolite toxicity assessment;

the zonal approach to authorisation of active substances and plant protection

preparations;

data requirements for biological substances and biopesticides; and

data protection issues.

Detailed comments on the above recommendations are given below.

6.1 A risk-based approach for the assessment

Implementation of a risk-based approach for AS substance assessment is feasible assuming that more

focus will need to be given on actual exposure compared to the sole assessment of intrinsic toxic

potency of the active substances for hazard assessment (today’s paradigm). A number of studies

addressing general, farmer/applicator and consumer exposure to pesticides in Europe have been

funded over the last decade from the European Commission RTD Framework Programmes and from

EFSA (in more targeted form). The information drawn from these initiatives should be collated and

put to use for exposure assessment purposes within the regulatory framework, effectively supporting

the widespread implementation of a risk-based assessment process. Some experts have argued that

such a move would increase regulatory complexity. However, the current experience from the

pesticide programme of the US EPA and from the REACH Regulation in Europe shows that

implementing a risk-based approach does not result in overburdened regulatory processes if done

properly. The benefit towards rationalisation of the assessment process and cost-efficiency of the

assessment could be significant. Additional benefits would include a spur of industrial innovation in

terms of both pesticide manufacturers and agricultural industry. The economic benefits would in this

case not be coupled to increased risks to environmental and human health. An adequately informed

risk assessment process would protect appropriately both the natural ecosystem and public and

consumer health.



It has been suggested that targeted case studies could be funded to provide specific evidence on the

actual environmental and health burden from the introduction of specific cut-off criteria. This would

be beneficial, of course, by means of providing a robust scientific basis for making the regulatory

change. It is not expected, however, to result in any significant difference compared to the savings

estimate given in the study, namely between 415 and 820 M€.

The information/data requirements for a comprehensive risk assessment would need to be regularly

reviewed and adapted to reflect scientific progress and knowledge enhancement with regard to both

the toxicity mechanisms and the fate of active substances and formulations in the environment and

the human body. Such revisions would need to be accompanied by the necessary guidance to both

industry and the regulatory competent authorities. Such reviews should only be done during pre-

determined intervals (e.g. every 5 or, better, 10 years) in order to ensure cost-effectiveness and the

smooth operation of both the market and the overall farming system.

Removal of the current requirements for comparative assessment of active substances and of the

criteria for substitution of the authorised pesticides would encourage industrial and farming

innovation. Coupling this to a more efficient risk-based assessment approach would ensure the

adequate protection of people and the environment at a very low cost of implementation.

6.2 Scoping the protection goals

Setting priorities in the protection goals of the Regulation including both environmental and health

aspects would also improve the efficiency of the overall system, allowing everyone to focus resources

on the most important issues. This change bears the potential for significant savings to the overall

agricultural/farming system while protecting adequately the environment and human health. In doing

that, however, care must be taken to consider not only the ecosystem goods and services that people

gain from the environment, but also the structural and functional features of ecosystems in order to

ensure their long-term sustainability. In this context, there is a need for clarification of monitoring

needs in order to render the monitoring system more cost-effective. Analysis of the relative

distribution of species sensitivity to pesticides and consideration of potential synergistic effects of

persistent and bioaccumulative substances would need to be included in the new monitoring regime.

6.3 Targeted and prioritised data requirements

More dramatic recommendations such as the reduction and streamlining of the tests considered

necessary under the current (hazard-based) regulatory regime would seemingly meet opposition at

the European Parliament. This notwithstanding, a re-evaluation of the necessity of each test should

be considered, especially if we move towards a more risk-based approach. Certain expensive and

time-consuming tests might not be necessary if manufacturers can prove that environmental or

human exposure to the substances in question is negligible. This, however, would have to be reviewed

in the framework of an integrated testing strategy, which would couple exposure and toxic potency

considerations to ensure adequate protection of human and ecosystem health. It has to be noted that

such an overhaul would bear very significant benefits to the cost-effectiveness of the overall risk

assessment and management system.



Environmental data requirements could be linked to the scale of use of active substances, resulting in

significant enhancement in terms of cost-efficiency of the risk assessment process (this modification

would be perfectly compatible with a move towards a risk-based assessment process, since scale of

use could act as a first proxy of exposure). However, in this case, specificities such as due

consideration of possible impacts on more sensitive population subgroups or ecosystem functions

would have to be taken into account in drawing these links. Data requirements for impurities and

active substance metabolites could be evaluated based on QSARs used on a case by case basis to

support toxicological evidence. This would create savings to industry without jeopardising

environmental and human health protection.

It is possible to display an acceptable risk based on a small dataset if the calculated RAC (regulatory

acceptably concentration) is sufficiently high. This modification is in agreement with the use of

assessment factors accounting for data uncertainty in the current Biocides regulatory regime. The

change would bring financial savings to industry and time saving to the MS regulatory authorities for

risk assessment completion. No increase in environmental risk is expected.

For acute toxicity testing, it is recommended to adopt the ILSI/HESI revised testing scheme. This

would decrease significantly the number of laboratory animals necessary, resulting in significant

benefits to both industry and regulatory authorities while protecting adequately human health and

the environment.

6.4 Zonal approach

Generalising the zonal approach and rendering it obligatory for authorisation is a key change that

would bring about significant cost reductions to industry and regulatory authorities, as well as

resulting in ultimate environmental benefits from the coherent implementation of assessment results.

In relation to the zonal approach, a potential way to simplify procedures would be to establish a ‘one-

stop-shop’ in the risk assessment process that is followed in the implementation of the authorisation

procedure. EFSA could play this role, much like ECHA’s role in the risk assessment and authorisation

or restrictions procedures followed in the chemical safety legislation (REACH Regulation).

Establishing a single interlocutor for the pesticides industry with whom to discuss the

scientific/technical aspects of product authorisation could significantly reduce the financial burden

both for industry and for MS competent authorities. At the same time, this option would simplify the

overall system. Mutual authorisation would no longer be required since the whole procedure would be

technically managed by EFSA.

The opinion expressed by EFSA could be developed with the assistance of a risk assessment expert

committee, comprising MS experts. The discussions in the committee would be of scientific/technical

nature, focusing on the evaluation of the product compliance with the requirements set by the

Regulation regarding authorised use of the product.

Clearly, individual MS could maintain the right to restrict or even ban the use of AS or of commercial

preparations sold as PPPs in their territory (much like the current legislation foresees). This could be

done on the basis of considerations regarding special agro-climatic characteristics of the national

territory, or even on the basis of need to protect public health taking into account the social-economic

conditions of the country (i.e. taking into account the realistic PPP application and use practices as per



the experience of the national competent authority) and the ways in which the latter influence

population exposure.

Final authorisation or restriction decisions would still have to be made on the basis of a common

decision (i.e. through a MS committee). This committee, however, would be expected to act on the

basis of political considerations and, if necessary, national sensitivities with regard to exposure to

PPPs. It would not be expected to question the EFSA opinion.

The advantage of the system proposed above is that it follows a relatively simple line in the flow of

information and the decision-making processes involved in the authorisation of PPPs to enter the

internal market. It resembles the corresponding procedure foreseen under REACH; thus, the PPP

community would benefit from the experience acquired in REACH in order to streamline any

operational efficiency issues.

In order for such a system to function, industry would have to provide the Agency with the complete

AS/PPP dossier, thus allowing the expert committee(s) of the Agency to efficiently review and assess

the respective risk profiles. If the submitted dossier were not complete, the timeline of the

authorisation procedure would have to be paused until industry complements the missing

information.

To summarise, a clear possibility to streamline Article 9 of the Regulation is provided if a one-stop

procedure is applied for each dossier application. In particular, if as proposed above, EFSA (or a similar

Community body) were responsible for the management of the risk assessment process, then the

only communication line necessary for admission of the application would be between the Agency

and the applicant. Until the application is accepted for further consideration by the Agency, no

exchange of information with other MS authorities or the Commission are necessary. In this way, red

tape is limited to the minimum and all interested parties are aware of the fact that they have to

consult the Agency for information concerning PPPs applications.

6.5 The specific case of biological substances

In the case of biological substances and biopesticides separate data requirements accompanied by

the provision of adequate guidance on use would be needed to ensure a cost-effective regulatory

regime. Even though developing separate data requirements would entail administrative costs the

significant efficiency gains expected from the implementation of these requirements would be

expected to reduce the net cost to minimal levels. Thus, such a development is highly recommended.

6.6 Data protection issues

Data protection is considered an issue that is way too sensitive to be left to industry alone to handle.

Some level of involvement of the competent authorities in the MS is deemed necessary to ensure that

no unfair market advantage is gained by specific market actors while maintaining the quality and

quantity of the data necessary for adequate human and ecosystem health protection.

Overall, there is a number of possible modifications to the current structure and scope of the

Regulation that are widely considered plausible by the experts consulted in this process and by the



project team. Effectiveness, feasibility and cost-benefit aspects have been considered in this

assessment. Based on these high-level criteria several of the policy options studied were dropped

because they were either difficult and/or unfeasible to implement, or they would incur excessive costs

to industry and/or regulatory authorities in such a way that the costs would outweigh the potential

benefits. Such options include removal of efficacy data and replacement by an approach similar to

the one used in the US (“let the market decide”); and revision of limit concentrations of active

substances in groundwater based on the outcome of a risk assessment and/or the WHO safety

guidelines, i.e. dropping the current threshold (0.1 μg/L) as unreasonably precautionary. In both cases,

more detailed cost-benefit analysis needs to be undertaken on the basis of specific case studies,

which would help forge a feasible regulatory change.

In conclusion, the bundle of policy modification options outlined above are considered as parts of a

feasible restructuring of the current regulatory regime in order to enhance the cost-effectiveness of

the system without jeopardising the protection to human and ecosystem health. The overall cost of

implementation of the policy options described above is reasonable - the potential benefits both with

regard to streamlining and simplification of the regulatory process and with regard to spurring

innovation in plant protection product manufacturing and farming in Europe clearly outweigh the

investment cost. Furthermore, the time required for implementation is reasonable; all changes in the

Regulation could be brought about within the normal regulatory review period. The development of

the necessary guidelines for the implementation of some of the novel aspects proposed herein should

not take exorbitant amounts of time. Thus, the whole regulatory simplification procedure would not

take more than twelve to eighteen months.

Annex A: Hazard versus risk-based approach in EU legislation


Annex A: Hazard- versus risk-based approach in EU legislation

This section examines various EU Regulations and Directives in respect of their approach to the

classification of chemicals, focusing on whether the legislation adopts a risk-based approach or

whether the approach is solely or mainly hazard-based. This section examines, first, the general

principles of classification under EU legislation. It then examines legislation for specific

substances and products.

In particular, this section examines the Biocidal Products Regulation, not only due to its similarity

to Regulation 1107/2009 in that it covers non-agricultural pesticides, but also because it contains

exclusion criteria that are similar to the cut-off criteria in Regulation 1107/2009. The Biocidal

Products Regulation, therefore, appears to provide an indication of the scope for simplification of

Regulation 11o7/2009.

Hazard assessment versus risk assessment

Hazard assessment means identifying the nature and severity of the possible adverse effects that

a chemical can cause humans (e.g. carcinogenicity, eye irritation, reproductive effects) or the

environment (e.g. effects on fish, birds, vegetation). Hazard identification is based on the

intrinsic properties of that chemical and the adverse effects associated with those properties.

The fact that the hazard evaluations focus solely on the intrinsic properties of a chemical is

critical, in that these evaluations do not take into account the possibility, nature or extent of any

actual human or environmental exposure to the chemical. Hazard assessment is one of the three

steps followed in a risk assessment.

In a risk-based assessment, there are two additional steps complementing the hazard

assessment: an exposure assessment and, finally, a risk characterisation (see Error! Reference

source not found. below). Exposure assessment is the evaluation of the nature and probability of

human or environmental exposure to the chemical. Risk characterisation is then carried out by

combining the results of the hazard assessment and exposure assessment. Controls can then be

placed on the use of the chemical in order to minimise or avoid the risks posed by its use.

An authorisation process purely based on hazard assessment can be considered as being more

protective, from an environmental and health point of view, as it may lead to the prohibition of a

substance even if the exposure of the receptors is negligible (e.g. because of the short duration or

small likelihood of exposure, because of the physical form of the substance, etc.). An

authorisation process based on risk assessment takes a more pragmatic approach as it considers

both intrinsic hazard properties of the substance and the exposure of the receptors. However,

assessing exposure generally adds to the complexity of the overall process, since it can be

challenging to obtain relevant exposure data and it may require a number of assumptions to be

made, leading to additional uncertainties in the final results of the assessment .

As detailed in this section, both approaches are used in EU legislation.



Classification of chemicals under EU legislation

Two EU Directives set out the main principles by which a large proportion of chemicals are

classified. The Directives are:

Directive 67/548/EEC on the approximation of laws, regulations and

administrative provisions relating to the classification, packaging and labelling

of dangerous substances, as amended, provides for a risk assessment approach

for the classification of dangerous substances (DSD); and

Directive 1999/45/EC concerning the approximation of the laws, regulations

and administrative provisions of the MS relating to the classification,

packaging and labelling of dangerous preparations, as amended (DPD).

In addition to classification, these Directives also cover labelling and packaging requirements for

chemicals.

Dangerous Substances Directive

Section 1.1 of Annex VI of the DSD states that the objective of classifying chemicals is to identify

all their physicochemical, toxicological and ecotoxicological properties ‘which may constitute a

risk during normal handling or use’.

The approach set out in Annex VI is risk-based. As commented by the European Court of Justice

in Nickel Institute v Secretary of State for Work and Pensions16, classification under the DSD

involves two stages:

hazard identification, defined as ‘the identification of the adverse effects which

a substance has an inherent capacity to cause’; and

risk characterisation, which ‘consists in estimating the incidence and severity

of the adverse effects likely to occur in a human population or environmental

compartment due to actual or predicted exposures to a substance, and that

characterisation may include quantification of that likelihood or, in other

words, risk estimation’.17

In other words, the DSD follows a risk-based approach.

16

ECJ, Case C-14/10, Reference for a preliminary ruling from High Court of Justice (England & Wales), Queen's Bench

Division (Administrative Court) made on 11 January 2010 — Nickel Institute v Secretary of State for Work and Pensions.

17 ECJ, Case C-14/10, paras 11, 12 (21 July 2011); see also Etimine S.A. v Secretary of State for Work and Pensions (ECJ,

Case C-15/10, 21 July 2011) (“Section 1.1 of Annex VI to Directive 67/548 states inter alia that the object of classification

is to identify all the physiocochemical, toxicological and ecotoxicological properties of substances and preparations

which may constitute a risk during normal handling or use”).



Dangerous Preparations Directive

The DPD also adopts a risk-based approach. Article 4(2) of the DPD states that the general

principles of classifying preparations shall, with certain exceptions, be applied in accordance with

the criteria set out in Annex VI to the DSD.

CLP Regulation

The DSD and the DPD are being replaced18 by Regulation (EC) No 1272/2008 on classification,

labelling and packaging of substances and mixtures (CLP Regulation) which entered into force on

20 January 2009. The CLP Regulation substitutes the approach of the United Nations Globally

Harmonised System of Classification and Labelling (GHS). The purpose of the GHS is the

establishment of an internationally harmonised approach to classification and labelling in order

to protect human health and the environment. The GHS classifies chemicals by types of hazard

and then provides for various means such as labelling and safety data sheets, to communicate

the hazard.

Article 1(a) of the CLP Regulation defines that the purpose of the Regulation is ‘to ensure a high

level of protection of human health and the environment as well as the free movement of

substances, mixtures19 and articles [by] harmonising the criteria for classification of substances

and mixtures, and the rules on labelling and packaging for hazardous substances and mixtures’.

The CLP Regulation is based on a risk assessment approach.

Recital 10 provides that the ‘objective of this Regulation should be to determine which properties

of substances and mixtures should lead to a classification as hazardous, in order for the hazards

of substances and mixtures to be properly identified and communicated. Such properties should

include physical hazards as well as hazards to human health and to the environment, including

hazards to the ozone layer’.

Further, Article 9(5) provides that the forms of physical states in which a substance or mixture is

placed on the market ‘and in which it can reasonably be expected to be used’ should be

considered when the substance or mixture is being evaluated in order to classify it.

The CLP Regulation sets out the following categories for substances based on their carcinogenic,

mutagenic or toxic to reproduction properties (known as ‘CMR’ properties).

a substance is classified as category 1A if there is sufficient evidence to

establish a causal link between human exposure to it and ill health.

a substance is classified as category 1B if there is sufficient evidence for a

strong presumption that human exposure to it may result in the development

of ill health; the presumption is generally based on long-term animal studies.

18 See Regulation (EC) No 1272/2008, art. 61 (setting out transitional provisions for the Regulation to be applied in

Member States).

19 The term “mixture” replaces the previous term “preparation”. See CLP Regulation, recital 14.



a substance which causes concern but for which there is not sufficient

information for a satisfactory assessment in order to place a substance in

category 1A or 1B is classified as category 2.20

A mixture is classified in the above three categories if it contains a component classified as CMR

at a concentration that is equal to, or exceeds, concentration limits defined in Annex I of the CLP

Regulation.

The CLP Regulation has been applied to substances, replacing the DSD, since 1 December 2010.

It will apply to mixtures, replacing the DPD, after 1 June 2015. There are two-year transition

periods for manufacturers and importers to reclassify and re-label substances and mixtures under

the CLP Regulation if they have already been classified, packaged, labelled and placed on the

market.

The CLP Regulation, like the DSD and the DPD, does not cover all substances and mixtures.

Article (5) provides that the Regulation does not apply to substances and mixtures which are in

the following forms, in a finished state, and are intended for the final user:

medicinal products under the Medicinal Products Directive (2001/83/EC);

veterinary medicinal products under Directive 2001/82/EC;

cosmetic products under the Cosmetic Products Directive;

medical devices under Directives 90/385/EEC and 93/42/EEC which are invasive

or used in direct physical contact with the human body [and in Directive

98/79/EC); and

food or feeding stuffs under Regulation (EC) No 178/2002, including their use

as:

food additives in foodstuffs under Directive 89/107/EEC;

flavouring in foodstuffs under Directive 88/388/EEC and

Decision 1999/217/EC;

an additive under Regulation (EC) No 1831/2003; and

in animal nutrition under Directive 82/471/EEC.

Authorisation of Biocidal Products

The EU legislation governing the authorisation of biocidal products is moving from a Directive to

a Regulation.

Biocidal Products Directive

20

The categories were called 1, 2 and 3 under the DSD.



Directive 98/8/EC concerning the placing of biocidal products on the market (‘Biocidal Products

Directive’) is similar to Regulation 1107/2009 because it governs non-agricultural pesticides. This

Directive adopts a risk–based approach.21

The purpose of the Biocidal Products Directive is to harmonise the procedures for placing biocidal

products on the EU market, conditional upon a high level of protection for human and animal

health and the environment. It provides for the authorisation of existing and new biocidal

products. The first stage is for the EC to test and authorise AS that are contained in biocidal

products and to place them in a list (known as the Annex I list). MS then authorise biocidal

products containing the EU-authorised AS.

The Directive contains risk-assessment criteria. Recital 8 provides that ‘whereas it is necessary,

when biocidal products are being authorised, to make sure that, when properly used for the

purpose intended, they are sufficiently effective and have no unacceptable effect on the target

organisms such as resistance or unacceptable tolerance, and, in the case of vertebrate animals,

unnecessary suffering and pain, and have, in the light of current scientific and technical

knowledge, no unacceptable effect on the environment and, in particular, on human or animal

health’.

Recital 11 states that: ‘Whereas, in the light of the diversity of both the AS and the biocidal

products concerned, the data and test requirements should suit the individual circumstances and

result in an overall risk assessment’.

Biocidal Products Regulation

The Biocidal Products Directive is being replaced by the Regulation concerning the making

available on the market and use of biocidal products (‘Biocidal Products Regulation’) which will

be phased into the domestic law of MS from 1 September 2013. Reasons for the replacement of

the Directive include:

the need to simplify and streamline the authorisation procedure;

inconsistencies in application between MS;

high compliance costs, particularly for SMEs; and

the backlog in the authorisation process for existing AS in biocidal products,

which had to be extended because the Commission did not finish its review

process by the deadline of 14 May 2010.

On 10 May 2012, the European Council adopted the Biocidal Products Regulation22 and it will be

published in the Official Journal in the near future.

21

See European Commission, Analysis of the Potential Effects of the Proposed GHS Regulation on Its EU Downstream Legislation, section II.1.1., p. 94 (“The Directive is based on risk: Harmonised community provisions for evaluation and rules for inclusion on a positive list of active substances, followed by authorisation of biocidal products will provide the control of risks posed by biocidal products”).

22 See Council of the European Union, Council tightens controls on biocidal products, 9757/12 (10 May 2012).



This Regulation changes the risk assessment procedure contained in the Biocidal Products

Directive. In brief, the Regulation introduces hazard-based cut-off criteria (known as ‘exclusion

criteria’) for AS in biocides. There are exceptions to the authorisation of AS that fall within the

exclusion criteria. Whereas these exceptions are narrow, they are broader than the exceptions in

Regulation 1107/2009, as discussed below. Further, if an exception is satisfied and the biocidal

product containing the active substance is authorised, the product becomes a candidate for

substitution.

The following provisions are from the version of the Regulation that was published on 19 April

2012.23 It should be noted that some of these provisions closely resemble provisions in Regulation

1107/2009. In particular, the exclusion criteria are markedly similar to those in section 3.6 of

Annex II of Regulation 1107/2009.

Precautionary principle

As in Regulation 1107/2009, the Biocidal Products Regulation is based on the precautionary

principle. Recital 3 states, in part, that the ‘Regulation should be underpinned by the

precautionary principle to ensure that the manufacturing and making available on the market of

AS and biocidal products do not result in harmful effects on human or animal health or

unacceptable effects on the environment’.

Hazard-based criteria and exceptions

As indicated above, the Biocidal Products Directive contained hazard-based exclusion criteria

which ban the authorisation of an active substance:

that has CMR properties classified as, or which meet the criteria to be classified

as, category 1A and 1B under the CLP Regulation;

that is considered to have endocrine disrupting properties that may cause

adverse effects in humans; or

that fulfils the criteria for being persistent, bio-accumulative and toxic or very

persistent and very bio-accumulative (article 5(1)).

Article 15(2) provides exceptions to the use of an active substance that is banned due to the

application of the hazard-based criteria. It states that an active substance that falls within any of

the three criteria set out above shall not be approved unless the substance satisfies at least one

of the following conditions:

(a) ‘the risk to humans, animals or the environment from exposure to the active substance in

a biocidal product, under realistic worst case conditions of use, is negligible, in particular

where the product is used in closed systems or under other conditions which aim at

excluding contact with humans and release to the environment;

(b) it is shown by evidence that the active substance is essential to prevent or control a

serious danger to human health, animal health or the environment; or

23

European Union, Regulation (EU) No …2012 of the European Parliament and of the Council of … concerning the making available on the market and use of biocidal products (PE-CO_ S 3/12, 2009/0076 (COD), 19 April 2012).



(c) not approving the active substance would cause disproportionate negative impacts on

society when compared with the risk to human health, animal health or the environment

arising from the use of the substance’.24

These exceptions are reiterated in recital 12, which provides that:

‘With a view to achieving a high level of protection of human health, animal health and

the environment, AS with the worst hazard profiles should not be approved for use in

biocidal products except in specific situations. These should include situations when

approval is justified because of the negligible risk from exposure to the substance, human

health, animal health or environmental reasons or the disproportionate negative impact

for society of non-approval. When deciding if such AS may be approved, the availability

of suitable and sufficient alternative substances or technologies should also be taken into

account’.

If an exception to the hazard-based criteria applies, risk mitigation measures must be used.

Article 15(2) provides that:

‘[w]hen deciding whether an active substance may be approved in accordance with

[article 15(1)], the availability of suitable and sufficient alternative substances or

technologies shall be a key consideration.

The use of a biocidal product containing AS approved in accordance with this paragraph

shall be subject to appropriate risk-mitigation measures to ensure that exposure of

humans, animals and the environment to those AS is minimised. The use of the biocidal

product with the active substance concerned shall be restricted to those MS in which at

least one of the conditions set out in this paragraph is met’.

The exceptions in Regulation 1107/2009 contrast, however, with the above exceptions in the

Biocidal Products Regulation. The exceptions to an AS (safener or synergist) that is banned due

to the application of the hazard-based criteria in Regulation 1107/2009 are as follows:

if ‘exposure to humans to that active substance, safener or synergist in a plant

protection product, under realistic proposed condition of use, is negligible’

(Annex II ,para. 3.6.3); or

the use of ‘an active substance is necessary to control a serious danger to plant

health which cannot be contained by other available means including non-

chemical methods’; in which case the active substance may be authorised,

subject to the approval by the EC and other MS, but only for a period not

24

The exclusion criteria in the proposed Regulation provided that:

“Notwithstanding Article 4(1), active substances referred to in paragraph 2 shall be included in Annex I only if at least one of the following conditions is met: (a) the exposure of humans to that active substance in a biocidal product, under normal conditions of use, is negligible, in particular where the product is used in closed systems or strictly controlled conditions; (b) it is shown that the active substance is necessary to control a serious danger to public health; (c) it is shown that not including the active substance in Annex I would cause disproportionate negative impacts when compared with the risk to human health or the environment arising from the use of the substance and that there are no suitable alternative substances or technologies”.

European Commission, Proposal for Regulation concerning the placing on the market and use of biocidal products (COM)2009 267 final, art. 5 (12 June 2009).



exceeding five years and provided that mitigation measures are used (Article

4.7).

The exceptions are reiterated in recital 32, which provides that:

‘In exceptional cases, MS should be permitted to authorise plant protection products not

complying with the conditions provided for in this Regulation, where it is necessary to do

so because of a danger or threat to plant production or ecosystems which cannot be

contained by any other reasonable means. Such temporary authorisations should be

reviewed at Community level’.

Thus, whereas the Biocidal Products Regulation has a greater number of exceptions which can be

used in ‘specific situations’; Regulation 1107/2009 has two exceptions which may be used only in

‘exceptional cases’.

The Biocidal Products Regulations also cover the use of biocidal products by the general public.

The authorisation of products with specified criteria is banned but this is subject to a narrow

exception that not authorising the product ‘would result in disproportionate negative impacts for

society when compared to the risks to human health, animal health or the environment arising

from the use of the biocidal product under conditions laid down in the authorisation (article

19(5))’. As with the exceptions discussed above, the exception concerning products used by the

general public is ‘subject to appropriate risk mitigation measures to ensure that exposure of

humans and the environment to that biocidal product is minimised’ (Article 19(5)).

Approaches in other EU legislation

The following describes the risk-based or pure hazard-based approach in other EU legislation for

the classification of chemicals and substances.

REACH

Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and

Restriction of Chemicals (REACH) applies a risk-based approach.25

Annex I to REACH, which is entitled General Provisions for Assessing Substances and Preparing

Chemical Safety Reports, states that the purpose of the annex is ‘to set out how manufacturers

and importers are to assess and document that the risks arising from the substance they

manufacture or import are adequately controlled during manufacture and their own use(s) and

that others further down the supply chain can adequately control the risks’.

The controls on the use of chemicals vary according to their classification. Chemicals with some

CMR properties classified as category 1A or 1B, and which appear in a list in Annex XVII, entitled

25 See, eg, Nickel Institute v Secretary of State for Work and Pensions, para 29 (ECJ, Case C-14/10, 21 July 2011) (“It is

apparent from the recitals to the REACH Regulation that the current system, managed by ECHA, is intended to ensure a high level of protection of human health and the environment and to enhance the competitiveness of the chemicals sector and innovation. The REACH Regulation obliges undertakings which manufacture and import chemicals to evaluate the hazards and risks resulting from their use and to take the measures necessary to manage any risk identified”).



Restrictions on the Manufacture, Placing on the Market and Use of Certain Dangerous

Substances, Preparations and Articles, are restricted according to the concentration in

substances and preparations that are placed on the market. Such chemicals must be labelled:

‘Restricted to professional users’, and may not be sold to the general public.26 Their use is not,

however, banned by REACH.

REACH may, however, have a de facto hazard-based approach in some instances. In particular,

chemicals with CMR properties (as well as chemicals with persistent, bioaccumulative and toxic

and very persistent and very bioaccumulative properties) are automatically classified as

substances of very high concern (SVHC) due solely to their hazard classification. Classification as

a SVHC does not automatically mean that the chemical may not be used but it does mean that it

may be placed on the Annex XIV List (the use of chemicals on this list is subject to authorisation

by the EC) or a so-called Candidate List published by the European Chemicals Agency (ECHA)

(that is, a candidate for inclusion in the Annex XIV list).

Further, classification as a SVHC may result in significant market consequences. Among other

things, a company’s corporate responsibility policy may limit or prohibit the SVHC’s use in their

products. Further, a governmental authority may have a policy that prohibits products with

SVHCs from public procurement procedures.27

Cosmetics Regulation

EU legislation on cosmetics demonstrates that the EU’s approach is not necessarily away from a

risk-based approach towards a pure hazard-based approach.

Article 4b of Directive 76/768/EEC on the approximation of the laws of the MS relating to

cosmetic production (‘Cosmetics Directive’) applied pure hazard-based criteria to chemicals with

CMR properties that were classified as category 1 or 2 and which were listed in Annex I of the

DSD. The use of any chemical that fell within such criteria was automatically prohibited.

This situation is changing due to the coming into force of Regulation (EC) No 1223/2009 on

cosmetic products (‘Cosmetics Regulation’) which, with limited exceptions, will fully repeal the

Cosmetics Directive by 11 July 2013.

On 1 December 2010, the Cosmetics Regulation repealed article 4b of the Cosmetics Directive.

From that date, articles 15(1) and (2) of the Cosmetics Regulation apply. In lieu of the prohibition,

articles 15(1) and (2) allow for limited exceptions from the prohibition under article 4b of the

Cosmetics Directive.

Whilst article 15(1) maintains the ban on chemicals with CMR properties that are classified as

category 2 under Annex VI, Part 3 of the CLP Regulation, it permits the use of such chemicals in

cosmetic products provided that the substance has been evaluated by the EU Scientific

Committee on Consumer Safety and found safe for such use.

26

See REACH, OJ L396, pp. 404, 424,

27 See Kristina Nordlander, Carl-Michael Simon and Hazel Pearson, Ha\ard v. Risk in EU Chemicals Regulation, European

Journal of Risk Regulation 3/2010, p. 239, 248.



In addition, article 15(2) provides for exceptions to the prohibition of the use of chemical

substances that are classified as category 1A or 1B under the CLP Regulation provided that the

following conditions are satisfied. The conditions are:

compliance with food safety requirements in Regulation (EC) No 178/2002

laying down the general principles and requirements of food law;

no suitable alternative substances being available, as documented in an

analysis of alternatives;

the application being made for a particular use of the product category with a

known exposure; and

their evaluation and finding that they are safe for use in cosmetic products by

the EU Scientific Committee on Consumer Safety, in particular in view of

exposure to such products and taking into consideration the overall exposure

from other sources, in particular, vulnerable population groups.

Article 15(2) further provides for specific labelling of such cosmetic products to avoid their

misuse, ‘taking into account possible risks linked to the presence of hazardous substances and

the routes of exposure’.

Medicinal Products Directive

Directive 2001/83/EC on the Community code relating to medicinal products for human use

(‘Medicinal Products Directive’) adopts a risk-based approach.

Recital 2 of the Medicinal Products Directive states that the ‘essential aim of any rules governing

the production, distribution and use of medicinal products must be to safeguard public health’.

Recital 3 acknowledges that this objective ‘must be attained by means which will not hinder the

development of the pharmaceutical industry or trade in medicinal products within the

Community’. In determining which medicinal products may be placed on the market, recital 7

recognises that ‘harmfulness and therapeutic efficacy can only be examined in relation to each

other and have only a relative significance depending on the progress of scientific knowledge and

the use for which the medicinal product is intended. It further states that an application for

authorisation to market such a product must include particulars and documents to demonstrate

‘that potential risks are outweighed by the therapeutic efficacy of the product’.

Recital 8 provides that ‘[s]tandards and protocols for the performance of tests and trials on

medicinal products are an effective means of control of these products and hence of protecting

public health and can facilitate the movement of these products by laying down uniform rules

applicable to [them] and the compilation of dossiers and the examination of applications’.

In order to ensure the safety of a medicinal product that has been placed on the market, article 23

provides that after the holder of the authorisation has placed the product, it must ‘take account

of scientific and technical progress and introduce any changes that may be required to enable to

medicinal product to be manufactured and checked by means of generally accepted scientific

methods’.



General Product Safety Directive

Another Directive that has a risk-based approach is Directive 2001/95EC on general product

safety (‘General Product Safety Directive’).

The purpose of the General Product Safety Directive is to ensure that products that are placed on

the market are safe. Recital 4 provides that ‘In order to ensure a high level of consumer

protection, the Community must contribute to protecting the health and safety of consumers’.

The Directive defines a ‘safe product’ according to the risk posed by it during its use. That is,

article 2(b) defines a ‘safe product’ as:

‘any product which, under normal or reasonably foreseeable conditions of use including

direction and, where applicable, putting into service, installation and maintenance

requirements, does not present any risk or only the minimal risks compatible with the

product’s use, considered to be acceptable and consistent with a high level of protection

for the safety and health of persons, taking into account the following points in

particular:

(i) the characteristics of the product, including its composition, packaging,

instructions for assembly and, where applicable, for installation and

maintenance;

(ii) the effect on other products, where it is reasonably foreseeable that it will be

used with other products;

(iii) the presentation of the product, the labelling, any warnings and instructions for

its use and disposal and any other indication or information regarding the

product;

(iv) the categories of consumers at risk when using the product, in particular children

and the elderly’.

The feasibility of obtaining higher levels of safety or the availability of other products presenting

a lesser degree of risk shall not constitute grounds for considering a product to be ‘dangerous’.

Legislation on nanotechnology

In the absence of a single piece of EU legislation that specifically controls nanomaterials, the EP

has been adding controls for them to EU regulatory legislation. The purpose of the legislative

provisions is generally to provide specific controls for nanomaterials in lieu of the controls in the

legislation for the products that contain them.

For example, article 16(1) of the Cosmetics Regulation states that ‘For every cosmetic product

that contains nanomaterials, a high level of protection of human health shall be ensured’. Whilst

the Cosmetics Regulation does not bar the use of nanomaterials in cosmetic products, article 16

requires specific labelling and pre-market notification requirements for such products regardless

of the hazard classification of the product or its risk to human health. Article 16 provides for the

EC regularly to review the nanomaterials provisions of the Cosmetics Regulation ‘in the light of

scientific progress’. It further provides that the Commission shall, ‘where necessary, propose

suitable amendments to those provisions’, with the first review to be carried out by 11 July 2018.



In respect of nanomaterials, recital 66 of the Biocidal Products Regulation states that:

‘There is scientific uncertainty about the safety of nanomaterials for human health,

animal health and the environment. In order to ensure a high level of consumer

protection, free movement of goods and legal certainty for manufacturers, it is necessary

to develop a uniform definition for nanomaterials, if possible based on the work of

appropriate international fora, and to specify that the approval of an active substance

does not include the nanomaterial form unless explicitly mentioned. The Commission

should regularly review the provisions on nanomaterials in the light of scientific

progress’.

Legislation on Genetically Modified Organisms

Two Directives control genetically modified organisms (‘GMOs’) and micro-organisms in the EU.

They are:

Directive 2001/18/EC on the deliberate release into the environment of

genetically modified organisms (‘Direct Release Directive’); and

Council Directive 90/219/EEC on the contained use of genetically modified

micro-organisms (‘Contained Use Directive’).

Both Directives have a risk-based approach.

Article 4(2) of the Direct Release Directive states that, before a person submits a notification to

carry out the deliberate release of a GMO or the place a GMO on the market (or in a product on

the market), that person must ‘carry out an environmental risk assessment’. Annex II sets out the

principles for carrying out the environmental risk assessment.

Article 6(1) of the Contained Use Directive requires MS to ‘ensure that all appropriate measures

are taken to avoid adverse effects on human health and the environment which might arise from

the contained use of genetically modified micro-organisms’. Accordingly, article 6(2) states that

‘the user shall carry out a prior assessment of the contained uses as regards the risks to human

health and the environment that they may incur’. In carrying out the risk assessment, the user

takes due account of parameters specified in Annex III.

It can, of course, be argued that the Direct Release Directive and the Contained Use Directive

necessarily have a risk-based approach because a pure hazard-based approach would ban the use

of any genetically modified organisms and micro-organisms. The de facto moratorium on GMOs

in the EU and its implications, including litigation at the WTO, is another topic that is not relevant

to this project.

EU legislation to phase out the use of specified substances

One of the purposes of Regulation 1107/2009 and the Biocidal Products Regulation is obviously to

phase out AS that fail the cut-off / exclusion criteria. If this is the case, the Regulations could state

so explicitly instead of implicitly.

For example, Directive 200/60/EC establishing a framework for Community action in the field of

water policy (‘Water Framework Directive’) is more direct. Article 16(1) states that:



‘[t]he European Parliament and the Council shall adopt specific measures against

pollution of water by individual pollutants or groups of pollutants presenting a significant

risk to or via the aquatic environment, including such risks to waters used for the

abstraction of drinking water. For those pollutants measures shall be aimed at the

progressive reduction and, for priority hazardous substances …, at the cessation or

phasing-out of discharges, emissions and losses’.

Decision No 2455/2001/EC establishing the list of priority substances in the field of water policy

set out the first list of 33 substances or groups of substances. An additional 15 priority substances

have been proposed. They include PPP substances as well as substances used in biocidal

products. The Water Framework Directive also establishes a list of priority hazardous substances

to be phased out.

The difference between Water Framework Directive and its purpose in phasing out specified

substances from the aquatic environment, however, differs considerably from the de facto phase

out of substances under Regulation 1107/2009 and the Biocidal Products Regulation in that the

Water Framework Directive does not affect the use of the same substance in a non-aquatic

environment. The converse is true for Regulation 1107/2009 in which the same active substance

that is being phased out for use in a PPP is not being phased out when it is present in other

products and, thus, subject to other EU legislation.

Conclusions

There is no clear trend in EU legislation towards a risk-based approach from a pure hazard-based

approach or vice versa. For example, whereas the Biocidal Products Directive did not include pure

hazard-based criteria; such criteria have been added to the Biocidal Products Regulation albeit

with broader exceptions than exist in Regulation 1107/2009. In contrast, whereas the Cosmetics

Directive applied pure hazard-based criteria to ban the use of certain chemicals, the Cosmetics

Regulation has replaced this automatic ban with limited exceptions including a conclusion by the

EU Scientific Committee on Consumer Safety, following an evaluation of a chemical, that it is

safe for use. The evaluation of chemicals by the EU Scientific Committee thus changes the pure

hazard-based approach into a risk-based approach.

Further, there is a clear trend from Directives to Regulations due mainly to the ability of a

Regulation to come into force immediately and to avoid different versions of the regulatory

regime among the MS. This trend seems unlikely to change.

The recent adoption of the exclusion criteria in the Biocidal Products Regulation may mean that

it may be difficult for Defra to convince the Council, EP and EC to reject the use of hazard-based

criteria in Regulation 1107/2009. It may, however, be possible to persuade the EU bodies to

broaden the exceptions to the latter in view of the broader exceptions in the Biocidal Products

Regulation when Regulation 1107/2009 is reviewed. Much will, of course, depend on the socio-

economic implications of the hazard-based criteria in Regulation 1107/2009 compared with the

implications of the exclusion criteria for the future of biocidal use and the amount of biocidal

products that are affected. The implications may well differ considerably between the two

Regulations.



The following table summarises assessment approaches which are put forward by the EU

legislations which were discussed above.



Annex table 1: Assessment approaches of selected EU legislations

Legislation Contains pure hazard-based criteria

Risk-based criteria Comments

Pesticides Regulation

Yes; includes pure hazard-based criteria for authorisation Narrow exceptions

Pure hazard-based criteria added to latest legislation

Biocidal Products Regulation

Yes; includes pure hazard-based approach for authorisation Narrow exceptions but broader than Regulation 1107/2009

Pure hazard-based criteria added to latest legislation

REACH Does not include a pure hazard-based approach but classification of some chemicals as SVHC due to their hazards plus their placement on the Candidate List is, possibly, a de facto hazard-based approach

Risk-based approach

Restricts use of some chemicals to professional users rather than banning their use

Cosmetics Regulation

Risk-based approach

Cosmetics Regulation replaces pure hazard-based approach for some chemicals in Cosmetics Directive with risk-based approach subject to satisfaction of conditions

Medicinal Products Directive

Risk-based approach

General Product Safety Directive

Risk-based approach

No specific legislation for nanotechnology; included in other legislation

Hazard-based approach not adopted but specified conditions including labelling and pre-market notification apply to nanomaterial form of a substance

Legislation that applies to nanotechnology specifies that approval of an AS does not include nanomaterial form unless explicitly indicated

Direct Release Directive Contained Use Directive

Both Directives have a risk-based approach

Adoption of a pure hazard-based approach would arguably have banned all genetically modified micro-organisms and organisms



Application of the precautionary principle

This section discusses why the precautionary principle does not mandate a hazard-based

approach in Regulation 1107/2009 despite the basis of that Regulation, at least in part, on the

precautionary principle.

Article 1(4) of Regulation 1107/2009 provides that:

‘The provisions of this Regulation are underpinned by the precautionary principle in order

to ensure that AS or products placed on the market do not adversely affect human or

animal health or the environment. In particular, MS shall not be prevented from applying

the precautionary principle where there is scientific uncertainty as to the risks with regard

to human or animal health or the environment posed by the plant protection products to

be authorised in their territory’.

Recital 8 provides that:

‘The purpose of this Regulation is to ensure a high level of protection of both human and

animal health and the environment and at the same time to safeguard the

competitiveness of Community agriculture. Particular attention should be paid to the

protection of vulnerable groups of the population, including pregnant women, infants

and children. The precautionary principle should be applied and this Regulation should

ensure that industry demonstrates that substances or products produced or placed on

the market do not have any harmful effect on human or animal health or any

unacceptable effects on the environment’.

The last sentence of recital 8 combines two distinct topics. First, the precautionary principle

applies to the Regulation. Second, industry must demonstrate that substances or products that it

produces and places on the market do not have harmful or unacceptable effects. That is, if

industry can demonstrate that the use of a PPP does not result in harmful or unacceptable

effects, the precautionary principle does not apply, as discussed below.

The precautionary principle is contained in article 191 of the Lisbon Treaty. Article 191(1) provides

that:

‘Union policy on the environmental shall contribute to pursuit of … preserving,

protecting and improving the quality of the environment [and] protecting public

health’.

Article 191(2) provides that:

‘Union policy on the environment shall aim at a high level of protection [and] shall be

based on the precautionary principle and on the principles that preventive action should

be taken, that environmental damage should be rectified at source and that the polluter

should pay’.

The European Court of Justice (ECJ) has ruled, in Gowan Comércio Internacional e Serviços Lda v

Ministero della Salute, a case involving PPPs under Directive 91/414/EEC, that EU policy on the

environment must pursue the objective, among other things, of protecting human health, a



policy that is based in part on the precautionary principle.28 This does not mean, however, that

the precautionary principle applies to the entirety of Regulation 1107/2009. The ECJ further

stated, referring to the EC’s Communication on the precautionary principle, that the principle

‘may be applied only in the case of scientific uncertainty … resulting, inter alia, from data which

are inadequate, inconclusive, or imprecise’ (para. 68).

The EC’s Communication on the precautionary principle states that:

‘Whether or not to invoke the Precautionary Principle is a decision exercised where

scientific information is insufficient, inconclusive, or uncertain and where there are

indications that the possible effects on the environment, or human, animal or plant

health may be potentially dangerous and inconsistent with the chosen level of

protection’.29

Thus, if potentially negative effects result from a phenomenon, product or procedure and the risk

of such effects cannot be determined with sufficient certainty from a scientific evaluation, the

precautionary principle applies (Communication, section 5.1.3). If, however, scientific uncertainty

does not exist because the data is adequate, conclusive and precise, the precautionary principle

does not apply. If, therefore, an active substance that satisfies the above criteria is banned by the

hazard-based criteria in Regulation 1107/2009, its ban is not due to the application of the

precautionary principle.

The issue also arises as to whether the application of the hazard-based criteria to an active

substance for which there is scientific uncertainty accords with the Commission’s

Communication. In this respect, the Commission has stated that the precautionary principle

should be considered as part of a structured approach to risk analysis that consists of risk

assessment, risk management and risk communication (section 4). There should be a scientific

evaluation of potential adverse effects on the environment, human, animal or plant health in

order to determine whether to invoke the principle. This evaluation, which should be as complete

as possible, ‘requires reliable scientific data and logical reasoning, leading to a conclusion which

expresses the possibility of occurrence and the severity of a hazard's impact on the environment

or health of a given population including the extent of possible damage, persistency, reversibility

and delayed effect’. The risk assessment should have ‘four components - namely hazard

identification, hazard characterisation, appraisal of exposure and risk characterisation ... An

attempt to complete these four steps should be performed before decision to act is taken’

(Communication, sections 5.1.2, 6.1).

The ECJ reiterated the application of the above measures in Gowan as follows:

‘A correct application of the precautionary principle presupposes, first, identification of

the potentially negative consequences for health of the proposed use of the substance at

issue, and, secondly, a comprehensive assessment of the risk to health based on the

most reliable scientific data available and the most recent results of international

research’ (para. 75).

28

Gowan Comércio Internacional e Serviços Lda v Ministero della Salute para. 71 (Case No C-77/09, 22 Dec. 2010).

29 Communication from the Commission on the precautionary principle (COM2000) 1 final, Summary section 1 (Feb. 2,

2000); available at http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:52000DC0001:EN:NOT

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:52000DC0001:EN:NOT



Further, the Commission’s Communication on the precautionary principle discusses the following

general principles of risk management:

proportionality;

non-discrimination;

consistency;

examination of the benefits and costs of action or lack of action; and

examination of scientific developments (section 6.3).

In respect of proportionality, the Commission stated that:

‘Measures based on the precautionary principle must not be disproportionate to the

desired level of protection and must not aim at zero risk, something which rarely exists.

… In some cases a total ban may not be a proportional response to a potential risk. In

other cases, it may be the sole possible response to a potential risk’.

In Gowan, the ECJ concluded that the EC’s application of the precautionary principle and the

principle of proportionality which effectively banned the use of fenarimol, despite a contrary

assessment by the UK Government, was justified (para. 83). As discussed, however, this case

involved the precautionary principle due to the endocrine disrupting properties of fenarimol.

In its Communication, the Commission further stated that:

‘Risk reduction measures should include less restrictive alternatives which make it

possible to achieve an equivalent level of protection, such as appropriate treatment,

reduction of exposure, tightening of controls, adoption of provisional limits,

recommendations for populations at risk, etc. One should also consider replacing the

products or procedures concerned by safer products or procedures’ (Communication,

section .3.1).

In respect of consistency, the Commission stated that, ‘Measures should be consistent with the

measures already adopted in similar circumstances or using similar approaches’ (Communication,

section 6.3.3)).

The use of hazard-based criteria in Regulation 1107/2009, however, arguably ignores Directive

20009/128/EC establishing a framework for Community action to achieve the sustainable use of

pesticides because it does not permit consideration of ways in which AS that fail the hazard-

based criteria can be used sustainably. Further, it does not take account of the use of risk-based

criteria for the same AS in products that are subject to other EU legislation.

Finally, a further argument why the precautionary principle is not applicable to the hazard-based

criteria is that it does not play a role in the identification and characterisation of a hazard

because, at that stage, the scientific evaluation is incomplete.30

30

See Kristina Nordlander, Carl-Michael Simon and Hazel Pearson, Ha\ard v. Risk in EU Chemicals Regulation, European

Journal of Risk Regulation 3/2010, p. 239, 241 .

Annex B: List of key documents reviewed


ANNEX B: List of key documents reviewed

ADAS (2008) Evaluation of the impact on UK agriculture of the proposal for a regulation of the European Parliament and of the council concerning the placing of plant protection products on the market – Report for ECPA

ADAS UK Ltd. for Defra (2010) Impact of changing pesticide availability on horticulture and an assessment of all impacts and priorities on a range of arable, horticultural and forage crops

Central Science Laboratory (2008) Evaluation of the impact of the proposed revisions to EU Directive 91/414/EEC on wheat production in the UK – Report for Defra

CLARKE/ADAS (2011) Impact of changing pesticide availability

Cranfield University (2008) WHAT PRICE PROTECTION? An Economic Assessment of the Impact of Proposed Restrictions on Crop Protection Substances

Damalas C.A. and Eleftherohorinos I.G. (2011) Pesticide Exposure, Safety Issues, and Risk Assessment Indicators. Int. J. Environ. Res. Public Health, 8, 1402-1419

Declaration of Ljubljana (2008) The impact of a declining European pesticide portfolio on resistance management, Outlooks in Pest Management (http://www.researchinformation.co.uk/pest/sample/S3-1906.pdf)

Defra, Proposal for a Regulation of the European Parliament and of the Council concerning the placing of plant protection products on the market – Summary of provisions; Summary of Impact Assessment

Defra, Partial Regulatory Impact Assessment (Annex D) – Published on HSE website: http://www.pesticides.gov.uk/guidance/industries/pesticides/topics/pesticide-approvals/eu/eu-thematic-strategy/partial-regulatory-impact-assessment-annex-d (concerns the proposal for a Regulation concerning the placing of plant protection products on the market)

Defra (2010) Consultation on the implementation of EU pesticides legislation; summary and government response

Defra (2010 and 2011) Impact assessment on Plant Protection Products: Enforcement Regulations and Fees Regulations

Drew associates (2006) The economic impact of Directive 91/414/EEC and legislation on MRLs – Report

EC (2006) Commission staff working document – Report on the Impact Assessment for a Regulation replacing Directive 91/414/EEC on plant protection products

EC (2006) Impact assessment on Thematic Strategy on the Sustainable Use of Pesticides – Executive summary (SEC(2006) 914) (http://ec.europa.eu/environment/ppps/pdf/sec_2006_0914.pdf)

http://www.researchinformation.co.uk/pest/sample/S3-1906.pdf

http://www.pesticides.gov.uk/guidance/industries/pesticides/topics/pesticide-approvals/eu/eu-thematic-strategy/partial-regulatory-impact-assessment-annex-d

http://www.pesticides.gov.uk/guidance/industries/pesticides/topics/pesticide-approvals/eu/eu-thematic-strategy/partial-regulatory-impact-assessment-annex-d

http://ec.europa.eu/environment/ppps/pdf/sec_2006_0914.pdf



European Crop Protection Association (ECPA), Stakeholder Consultation on Smart Regulation – Reply from the European Crop Protection Association

ECPA (2010) ECPA position: Regulatory considerations to encourage industry investment in minor use authorisations

ECPA (2011) Stricter criteria that jeopardizes re-authorization of key active substances begins in June

European Parliament, Directorate General Internal Policies of the Union, Policy Department Structural and Cohesion Policies, Agriculture and Rural Development (2008) The Consequences of the ‘cut off’ criteria for pesticides: alternative methods of cultivation (IP/B/AGRI/IC/2008_168, 1 December 2008) (http://www.europarl.europa.eu/RegData/etudes/note/agri/2008/408962/IPOL-AGRI_NT(2008)408962_EN.pdf)

Greenpeace Germany (2008) The Dirty Portfolios of the Pesticides Industry; Production Evaluation & Ranking of Leading Agrochemical Companies (http://www.greenpeace.org/eu-unit/en/Publications/2009-and-earlier/dirty-portfolios-of-pesticides-companies/

House of Commons Environment, Food and Rural Affairs Committee (2009) Securing food supplies up to 2050: the challenges faced by the UK

KEMI (2008) Interpretation in Sweden of the ‘cut-off’ criteria adopted in the common position of the Council concerning the Regulation of placing plant protection products on the market (document 11119/08)

Milieu (2008) The benefits of strict cut-off criteria on human health in relation to the proposal for a Regulation concerning plant protection products – Report for the European Parliament

Karabelas A.J. Plakas K.V. Solomou E.S. Drossou V.. Sarigiannis D.A (2009) Impact of European legislation on marketed pesticides — A view from the standpoint of health impact assessment studies. Environment International 35, 1096–1107

Kristina Nordlander, Carl-Michael Simon and Hazel Pearson (2010) Hazard v. Risk in EU Chemicals Regulation, European Journal of Risk Regulation 3/2010, p. 239, 241

Séan Rickard, Cranfield University School of Management (2008) What Price Protection? An economic assessment of the impact of proposed restrictions on crop protection substances

Stuart Creton, Ian C Dewhurst, Lesley K Earl, Sean C Gehen, Robert L Guest, Jon A Hotchkiss, Ian Indans, Michael R Woolhiser, Richard Billington (2010) Acute toxicity testing of chemicals-Opportunities to avoid redundant testing and use alternative approaches. Crit Rev Toxicol. ;40 (1):50-83 20144136. National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs), London, UK

RPA (2008) Study on the Benefits of Pesticide Regulation – Report for the UK PSD (Defra)

UK Pesticides Safety Directorate (PSD) (2008) Revised assessment of the impact on crop protection in the UK of the ‘cut-off criteria’ and substitution provisions in the proposed regulation of the European Parliament and of the council concerning the placing of plant protection products on the market

http://www.europarl.europa.eu/RegData/etudes/note/agri/2008/408962/IPOL-AGRI_NT(2008)408962_EN.pdf

http://www.europarl.europa.eu/RegData/etudes/note/agri/2008/408962/IPOL-AGRI_NT(2008)408962_EN.pdf

http://www.greenpeace.org/eu-unit/en/Publications/2009-and-earlier/dirty-portfolios-of-pesticides-companies/




UK Pesticides Safety Directorate (PSD) (2008) Plant protection products Regulation: agronomic implications of proposals in the EU




Annex C: Chronology of EU policy on pesticides


ANNEX C: Chronology of EU policy on pesticides

The key steps in the development of the EU policy on pesticides are presented in the table below.

:

Annex table 2: Key steps in the development of the EU policy on pesticides

Date Action Comments

21 December 1978

Directive 79/117/EEC First EU legislation to establish a list of prohibited and authorised active substances for use in plant protection products in the EU; deadline for implementation of 1 January 1981

15 July 1991 Directive 91/414/EEC entered into force

31

Based approval of new and existing active substances and products containing them on a risk assessment procedure

15 July 1993 Deadline for transposition of 91/414/EEC into MS domestic law

1992 Fifth Environmental Action Programme (1992-2000)

Included statement of aim ‘to achieve a substantial reduction of pesticide use per unit of land under production ‘

2001 Sixth Environmental Action Programme (2001-2010)

Sustainable use of pesticides listed as one of seven thematic strategies

Twin track approach adopted to minimise risks associated with the use of pesticides

1. ban or severely limit the placing on the market and use of the most hazardous and risky pesticides

2. ensure best practice is adopted regarding the use of the remaining authorised pesticides

2001 European Commission Progress Report on

Key proposed changes include

1. creation of 3 EU zones and mandatory mutual recognition of production authorisations in same zone

31 Directive 79/117/EEC prohibiting the placing on the market and use of plant protection products containing certain active substances. OJ L 33/36 (8 February 1979).




functioning of 91/414/EEC 2. new criteria for approval of active substances including toxicity and environmental hazard triggers

3. comparative assessment and substitution of products containing active substances identified as candidates for substitution

4. abolition of provisional authorisations for active substances at MS level and introduction of strict deadlines to speed up decision-making at EC level

30 May 2002 European Parliament Resolution

32

EP called on EC to submit a draft Directive before July 2003 to establish a programme to reduce pesticide use with quantitative targets, a schedule and supporting measures

November 2002

European Environmental Bureau and Pesticides Action Group publish Draft Directive on pesticides use reduction in Europe

33

27 March 2003 EP Resolution Clause 22:

‘Urges the Commission to draw up a new policy for pesticides in line with the forthcoming EU chemicals policy on the basis of the principles advocated in the conclusions of the Environment Council of 7 and 8 June 2001, with particular focus on substances which are carcinogenic, mutagenic or toxic to reproduction and substances which are persistent, bioaccumulating and toxic or which otherwise give cause for serious concern, particularly endocrine-disrupting substances and VPVB (very persistent, very bioaccumulating) substances; these substances should, in principle, be avoided in plant protection products; consistency between the revision of Regulation (EEC) No 2455/92 concerning certain dangerous chemicals and Directive 91/414/EEC should also be taken into account ‘

2005 Plant Protection Products Regulations 2005/1435

Transposed Directive 91/414/EEC and other legislation into UK law; repealed 24 September 2011

12 July 2006 EC submitted Proposal for Regulation concerning the

Included toxicity hazard triggers for following active substances

32

http://www.europarl.europa.eu/sides/getDoc.do?type=TA&reference=P5-TA-2002-0276&language=SL and http://www.europarl.europa.eu/sides/getDoc.do?type=REPORT&reference=A5-2002-0155&language=EN

33 Available at http://www.pan-europe.info/Archive/PURE/pure_campaign_directive.htm

http://www.europarl.europa.eu/sides/getDoc.do?type=TA&reference=P5-TA-2002-0276&language=SL

http://www.europarl.europa.eu/sides/getDoc.do?type=REPORT&reference=A5-2002-0155&language=EN

http://www.pan-europe.info/Archive/PURE/pure_campaign_directive.htm




placing of plant protection products on the market

1. carcinogenic, mutagenic or toxic for reproduction

2. substances with endocrine disrupting properties

3. persistent, bio-accumulative and toxic substances

4. very persistent or very bio-accumulative substances

12 July 2006 EC published impact assessment on Thematic Strategy on the Sustainable Use of Pesticides

34

Did not discuss cut-off criteria

Did not take account of the effect of the proposed Regulation on the competitiveness of EU agriculture, negative effects on crop yields, long-term effects on increasing dependency on imports, implications for food prices, etc.

12 July 2006 EC Communication on the Thematic Strategy on the Sustainable Use of Pesticides

35

19 July 2006 Council report on EC Proposal

36

12 September 2007

EP Committee on Environment, Public Health and Food Safety voted on proposal, 1

st reading

Stated that cut-off criteria will be used to exclude active substances in order to protect human health and the environment against intrinsic hazards of specified substances; active substances must not have any harmful effects on human health, especially users in close contact with products, residents, bystanders and vulnerable groups such as pregnant and nursing women, embryos and foetuses, infants and children

23 October 2007

1st

reading of Proposal in EP Extended cut-off criteria to neurotoxic and immunotoxic substances

11 March 2008 EC submitted amended proposal

37

Refused additional cut-off criteria proposed by EP

34

SEC(2006) 914 (12 July 2006).

35 COM(2006) 372 final (12 July 2006).

36 11755/06 (24 July 2006).




June 2008 Greenpeace Germany published ‘The Dirty Portfolios of the Pesticides Industry; Production Evaluation & Ranking of Leading Agrochemical Companies ‘

38

Ranked pesticide manufacturers according to hazards and risks of pesticides manufactured by them

23 June 2008 Agriculture Council meeting Agreed with cut-off criteria for mutagenic, genotoxic, carcinogenic, reprotoxic active substances as well as endocrine disrupters and substances classified as persistent, bioaccumulating and toxic

Council and EC agreed that neurotoxic and immunotoxic substances should be classified as candidates for substitution instead of banned

September 2008

Report prepared for EP Policy Department Economic and Scientific Policy published

39

Overviewed recent epidemiology studies that found strong associations between pesticide exposure and a range of health impacts; assessed some of the health benefits from eliminating exposure to certain active substances

Concluded, among other things, that ‘hazard-based cut-off criteria are justified where a preventive approach is needed ‘

15 September 2008

Council published Common Position

Adopted by qualified voting; Hungary, Ireland, Romania and UK abstained

22 September 2008

Swedish impact assessment published

40

Preliminary assessment of the impact on the number of approved active substances by applying the cut-off criteria

September Séan Rickard, ‘What price Examined implications of changing to a hazard-based approach; concluded the consequences will be serious

37

European Commission, Amended Proposal for a Regulation of the European Parliament and of the Council concerning the placing of plant protection products on the market (COM(2008) 93 final) (11 March 2008).

38 Available at http://www.greenpeace.org/eu-unit/en/Publications/2009-and-earlier/dirty-portfolios-of-pesticides-companies/

39 European Parliament, Policy Department Economic and Scientific Policy, The benefits of strict cut-off criteria on human health in relation to the proposal for a Regulation concerning

plant protection products (PE 208.559, IP/A/ENVI/ST/2008-18)

40 KEM (Swedish Chemicals Agency), Interpretation in Sweden of the ‘cut-off’ criteria adopted in the common position of the Council concerning the Regulation of placing plant protection

products on the market (document 11119/08).





2008 protection? ‘ published41

1 December 2008

EP Policy Department publishes ‘The consequences of the ‘cut off’ criteria for pesticides: alternative methods of cultivation ‘

42

Report recommended, among other things: ‘The need for more detailed impact assessments of the ‘cut-off’ criteria across the EU including economic, environmental and social impacts ‘ (page 5)

1 December 2008

EP Policy Department publishes ‘The consequences of the ‘cut-off’ criteria for pesticides: agronomic and financial aspects ‘

43

Report stated, among other things:

‘The Commission’s impact assessment came too early in the process … ‘ (page 3)

‘The introduction of hazard based approval criteria in the Regulation amending Directive 91/414/EEC concerning the placing on the market of plant protection products (PPP) is apparently necessitated as a result of the augmenting and influential concerns of some groups of

European citizens. On the other hand, a negative impact on the sustainability of European agriculture is speculated, according to various reports by competent authorities and stakeholders. Widespread ramifications are depicted as aggravating the already fragile arsenal of European crop protection, left currently at the disposal of the European farmer. This is the result of the withdrawal of almost 75% of active ingredients, accomplished through the implementation of risk based criteria provided by existing Directive 91/414/EEC. Such findings are contrary to the ones anticipated by the Commission and certain MS in favour of ‘cut-off’ criteria. The contradiction can be explained by the ambiguity generated from the lack of agreed scientific principles for the definition of some of the ‘cut-off’ criteria, namely the endocrine disrupting potential of a substance and some environmental criteria ‘ (page 31)

December 2008

Declaration of Ljubljana; The impact of a declining European pesticide portfolio

Declaration by scientists concerning implications of decreased number of pesticides

41

Séan Rickard, Cranfield University School of Management, What Price Protection? An economic assessment of the impact of proposed restrictions on crop protection substances (September 2008).

42 European Parliament, Directorate General Internal Policies of the Union, Policy Department Structural and Cohesion Policies, Agriculture and Rural Development, “The Consequences of

the ‘cut off’ criteria for pesticides: alternative methods of cultivation” (IP/B/AGRI/IC/2008_168, 1 December 2008).

43 43

European Parliament, Directorate General Internal Policies of the Union, Policy Department B Structural and Cohesion Policies, “The Consequences of the ‘cut off’ criteria for pesticides: agronomic and financial aspects” (IP/B/AGRI/IC/2008_166, 1 December 2008).




on resistance management

5 November 2009

EP Committee on Environment, Public Health and Food Safety voted, 2

nd

reading

13 January 2009

EP 2nd

reading

24 September 2009

Act approved by Council, 2nd

reading

24 November 2009

1107/2009 published in Official Journal

25 November 2009

Directive 2009/128/EC establishing a framework for Community action to achieve the sustainable use of pesticides entered into force

14 December 2009

1107/2009 entered into force Approval of active substances and products containing active substances based on hazard-based cut-off criteria

February 2010 Defra Consultation on the implementation of EU pesticides legislation

31 March 2010 Report by ADAS UK Ltd for Defra published: ‘Impact of changing pesticide availability on horticulture and an assessment of all impacts and priorities on a range of arable, horticultural and forage crops

Evaluated status of weeds, pests and disease in horticultural crop production and implications of enactment of 11/07/2009 and other EU legislation




‘

December 2010 UK Coalition Government introduces regulatory reform agenda including Principles of Regulation

44

14 June 2011 1107/2009 applies; 91/414/EEC repealed

20 August 2011 Plant Protection Products Regulations 2011/2131

Regulations to enforce 1107/2009 in UK entered into force

44

See http://www.bis.gov.uk/policies/bre/principles-of-regulation

http://www.bis.gov.uk/policies/bre/principles-of-regulation




Annex D: List of stakeholders and experts contacted


ANNEX D: List of stakeholders and experts contacted

Annex table 3: List of stakeholders contacted

Type Organisation Country Name Email Address

Pesticide manufacturer

Agrichem BV The Netherlands

Mr Bart Vanhoof

[email protected]


Agriphar S.A Belgium Mr Christophe Corman

[email protected]


Agrichem (International ) Ltd

UK Alison Williamson

[email protected]


Agroquimicos Genericos

Spain Ms Carmen Maria Mercado

[email protected]


Agriguard Ltd Ireland Sir/Madam (please forward to relevant person)

[email protected]

Consultant APC UK Mr Michael Hale

[email protected]


Barclay Chemicals Manufacturing Limited

Republic of Ireland

Mr Ian Flanagan

[email protected]


BASF plc UK Ms Pam P Moult

[email protected]


Bayer CropScience Limited

UK Mr M A Read [email protected]


Belchim Crop Protection France SA

France Sir/Madam (please forward to relevant person)

[email protected]


Certis UK Mrs Sue S Young

[email protected]


Chiltern Farm Chemicals Limited

UK Mrs S Tavener

[email protected]


Dow AgroSciences Limited

UK Miss Erica Palandri

[email protected]


Du Pont (UK) Limited Mr Steve Cranwell

[email protected]


Exosect Limited Mrs Janet Leach

[email protected]


Feinchemie Schwebda GmbH

Germany Dr Erika Schneider

[email protected]


Fine Agrochemicals Limited

UK Mr Iain I Watt [email protected]


FMC Chemical Sprl BELGIUM Mr Ron Vanpeer

[email protected]


GLOBACHEM nv BELGIUM Mr Koen Quaghebeur

[email protected]





Headland Agrochemicals Limited

UK Sir/Madam (please forward to relevant person)

[email protected]


Hermoo Belgium NV BELGIUM Ms Kathleen Vandenbranden

[email protected]


ISK Biosciences Europe NV

Belgium Mr Frederic Joris

[email protected]


Koppert (UK) Limited UK Mr D Flory [email protected]


Lanxess Distribution GmbH

Germany Mr Ralf Bogan

[email protected]


Makhteshim Agan Europe

Germany Mr Wolfgang Busch

[email protected]


Monsanto UK Limited UK Mr Maurice de Billot

[email protected]


Rohm and HAAS France S.A.S.

France Ms Blandine B Meiller

[email protected]


SCC GmbH Germany Dr Monika M Hofer

[email protected]


Scotts International BV The Netherlands

Marcel Strijdonk

[email protected]


SumiAgro (UK) Limited Mr David Collinge

[email protected]


Sumitomo Chemical Agro Europe SAS

France Mr Georges G De Wilde

[email protected]

Consultant TSGE UK Mr Matthew Curl

[email protected]


United Phosphorus Limited

UK Mr Robin R Ingham

[email protected]


W Neudorff GmbH KG GERMANY Sir/Madam (please forward to relevant person)

[email protected]

Farmers organisation

COPA-COGECA (Committee of Professional Agricultural Organisations - General Committee for Agricultural Cooperation in the EU)

EU Sir/Madam (please forward to relevant person)

[email protected]

Landowners organisation

European Landowners Organisation (ELO)

EU Ms Delphine DUPEUX

[email protected]

Chemicals industry federation

CEFIC (European Chemical Industry Council) - LRI program

EU Dr Bruno Hubesch

[email protected]




Chemicals industry federation

American Chemistry Council - LRI program

USA Dr Tina Bahadori

[email protected]

Pesticide producers federation

European Crop Protection Association (ECPA)

EU Mr Euros Jones

[email protected]

Agricultural association

AREFLH (Assemblée des régions européennes frutières légumières et horticoles)

EU Mr Jacques DASQUE

[email protected]

Agricultural association

AIC (Agricultural Industries Confederation)

UK Mr Paul Rooke

[email protected]

International organisation

OECD Pesticide Programme

Ms Sylvie Poret

[email protected]


Chemtura Europe Ltd Mr John Hemmings

Consultant European Agrichemicals Ltd

UK

Consultant JRF International UK


Nufarm UK Limited UK Mrs Jacqui J Taylor


Sipcam Phyteurop France Mr Philippe Kuenemann


Syngenta Crop Protection UK Limited

UK Ms Lorna L Spicer


The Scotts Company (UK) Limited

Ms Stephanie Souch

Farmers organisation

National Farmers' Union of England and Wales (NFU)

UK Mr Martin Haworth

NGO The Voluntary Initiative UK

Annex table 4: List of experts contacted


University Cranfield University School of Management

UK Séan Rickard [email protected]

University Imperial college UK Nick voulvoulis

[email protected]

Research institution

ECETOC (European Centre for Ecotoxicology and Toxicology of Chemicals)

EU Neil Carmichael

[email protected]

Research institution

IOM (Institute of Occupational Medicine)

International Martie van Tongeren

[email protected]

National Authority

US EPA (Environmental Protection Agency)

USA Anna Lowit [email protected]




University UC Berkeley USA Brenda Eskenazi

[email protected]

Consultant Independent consultant UK Terry Tooby [email protected]

Association ECPA (European Crop Protection Association)

EU Euros Jones [email protected]


Du Pont de Nemours BE Jean-Pierre Busnardo

[email protected]

Association ECCA (European Crop Care Association)

EU Hans Mattaar

[email protected]



06 September 2013

20-22 Villa Deshayes 75014 Paris

+ 33 (0) 1 53 90 11 80

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