Service contract for technical - European...

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Service contract for technical

assistance to review the existing Member State reporting

questionnaire under Article 117

REACH, including the evaluation and configuration of an

appropriate IT tool for the reporting

Final Report

April 2016

Ref. Ares(2016)2178823 - 10/05/2016

EUROPEAN COMMISSION

Directorate-General for the Environment

Directorate A – Green Economy

Unit A3 – Chemicals

Contact: Mateo Gallego

E-mail: [email protected]

European Commission

B-1049 Brussels

EUROPEAN COMMISSION

Directorate-General For the Environment 2016 EUR [Number] EN

Service contract for technical

assistance to review the existing

Member State reporting questionnaire under Article 117

REACH, including the evaluation

and configuration of an appropriate IT tool for the

reporting

Final Report

The original version of this Final Report was prepared by Claire Dupont, Florent Pelsy and Lise

Oulès for Milieu Ltd. under Contract No 2013/ENV.A.3/667720 with the European Commission,

DG Environment in 2016.

The views expressed herein are those of the consultants alone and do not necessarily represent the

official views of the European Commission.

Milieu Ltd. (Belgium), 112 Chaussée de Charleroi, B-1060, Brussels, tel.: +32 2 514 3601; Fax:

+32 2 514 3603; e-mail: [email protected] ; web address: www.milieu.be

mailto:[email protected]://www.milieu.be/

LEGAL NOTICE

This document has been prepared for the European Commission however it reflects the views only of the

authors, and the Commission cannot be held responsible for any use which may be made of the information

contained therein.

More information on the European Union is available on the Internet (http://www.europa.eu).

Luxembourg: Publications Office of the European Union, 2016

ISBN: 978-92-79-40742-0

Doi: 10.2838/4122

© European Union, 2016

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Service contract for technical assistance on the Member State reporting questionnaire under Article 117 of REACH

TABLE OF CONTENTS

ABREVIATION USED ......................................................................................... XIII

EXECUTIVE SUMMARY ......................................................................................... XV

INTRODUCTION ................................................................................................. 18

1 Theme 1 information on the CA ........................................................................ 19

1.1 Organisation of CA(s) for the operation of REACH .......................................... 19

1.2 Competences of CA(s) ............................................................................... 21

1.3 Human resources ...................................................................................... 24

1.4 Financial and technical resources ................................................................ 27

2 Theme 2: Information on cooperation and communication with other Member States, the European Chemicals Agency (ECHA) and the Commission ..................... 30

2.1 Communication and collaboration between Member States ............................. 30

2.2 Collaboration between authorities at national level ........................................ 30

2.3 Communication and collaboration with ECHA ................................................ 30

2.4 Communication between Member States and the Commission ......................... 31

3 Theme 3: Operation of the national helpdesk ...................................................... 32

3.1 Structure of the helpdesk ........................................................................... 32

3.2 Staff and financing of the helpdesk .............................................................. 33

3.3 Services offered by the helpdesk ................................................................. 34

3.4 Quality assurance ..................................................................................... 35

3.5 Number of enquiries received by national helpdesks per year .......................... 37

3.6 Cooperation between helpdesks .................................................................. 41

4 Theme 4: Awareness raising activities ............................................................... 42

4.1 Type of awareness raising activities carried out by CAs .................................. 42

4.2 Target audience ....................................................................................... 42

4.3 Effectiveness of awareness raising activities ................................................. 44

4.4 Website ................................................................................................... 45

5 Theme 5: information on the promotion of the development, evaluation and use of alternative test methods .................................................................................. 46

6 Theme 6: Information on the participation in REACH Commission and ECHA expert groups / committees (Forum, REACH Committee, MSC, RAC, SEAC, CARACAL, RNC,

Helpnet) ........................................................................................................ 48

6.1 Forum ..................................................................................................... 48

6.1.1 Effectiveness .................................................................................. 48

6.1.2 Concerns ....................................................................................... 48

6.1.3 Proposals for improvement ............................................................... 49

6.2 REACH Committee .................................................................................... 49

6.2.1 Effectiveness .................................................................................. 49


6.2.2 Concerns ....................................................................................... 50


6.3 Member States Committee (MSC) ............................................................... 51

6.3.1 Effectiveness .................................................................................. 51

6.3.2 Concerns ....................................................................................... 51


6.4 Risk Assessment Committee (RAC) .............................................................. 52

6.4.1 Effectiveness .................................................................................. 52

6.4.2 Concerns ....................................................................................... 53


6.5 Socio-economic Committee (SEAC) ............................................................. 54

6.5.1 Effectiveness .................................................................................. 54

6.5.2 Concerns ....................................................................................... 55


6.6 Competent Authorities for REACH and CLP (CARACAL) ................................... 57

6.6.1 Effectiveness .................................................................................. 57

6.6.2 Concerns ....................................................................................... 57


6.7 Risk Communication Network (RNC) ............................................................ 58

6.7.1 Effectiveness .................................................................................. 58


6.8 HelpNet Committee ................................................................................... 59

6.8.1 Effectiveness .................................................................................. 59

6.8.2 Concerns ....................................................................................... 60


7 7: Information on dossiers evaluation and substance evaluation activities .............. 61

7.1 Dossier evaluation .................................................................................... 61

7.1.1 Activities carried out by Member States .............................................. 61

7.1.2 Human resources ............................................................................ 62

7.1.3 Effectiveness of the dossier evaluation process .................................... 62

7.1.4 Follow-up actions ............................................................................ 64

7.2 Substance evaluation ................................................................................ 65

7.2.1 Activities carried out by Member States .............................................. 65

7.2.2 Collaboration with other Member States ............................................. 67

7.2.3 Cooperation between Member States and ECHA .................................. 67

7.2.4 Follow-up actions ............................................................................ 69

7.2.5 Problems encountered in substance evaluation .................................... 70

7.2.6 Human resources ............................................................................ 71


7.2.7 Financial resources .......................................................................... 73

8 Theme 8: Annex XV Dossiers (restriction and identification of SVHC) and other points related to identification of SVHC .............................................................. 75

8.1 Annex XV Restriction dossiers ..................................................................... 75

8.1.1 Activities carried out by CAs ............................................................. 75

8.1.2 Human resources ............................................................................ 77

8.1.3 Consultation of enterprises ............................................................... 79

8.2 Annex XV SVHC dossiers............................................................................ 80

8.2.1 Activities carried out by CAs ............................................................. 80

8.2.2 Human resources ............................................................................ 81

8.2.3 Consultation of enterprises ............................................................... 82

8.2.4 Coordination between ECHA and Member States during the implementation of the SVHC Roadmap ............................................... 83

8.2.5 Financial and human resources dedicated to SVHC identification ............ 83

9 Theme 9 and 10: Information of REACH and CLP enforcement activities ................. 84

9.1 Organisation of REACH and CLP enforcement ................................................ 84

9.1.1 National Enforcement Authorities ...................................................... 84

9.1.2 Coordination between NEAs .............................................................. 91

9.1.3 Resources dedicated to enforcement of REACH and CLP ........................ 92

9.2 Enforcement and inspection strategies ......................................................... 94

9.2.1 REACH enforcement strategies .......................................................... 94

9.2.2 REACH inspection strategy ............................................................... 98

9.2.3 CLP enforcement and inspection strategies ....................................... 100

9.3 Training of inspectors .............................................................................. 103

9.4 Sanctions and appeals (REACH and CLP) .................................................... 104

9.5 Difficulties encountered in enforcement ...................................................... 104

9.6 Cooperation between Member States on REACH and CLP .............................. 105

9.7 Enforcement activities ............................................................................. 106

9.7.1 Number of controls ........................................................................ 106

9.7.2 Prioritisation of controls ................................................................. 109

9.7.3 Compliance of dutyholders ............................................................. 124

9.7.4 Enforcement measures .................................................................. 132

10 Theme 11: Information on the effectiveness of REACH on the protection of human health and the environment, and the promotion of alternative methods, and innovation and competition ............................................................................ 137

11 Theme 12: Other issues and recommendations ................................................. 139

Annex 1: Skill available in national helpdesks ....................................................... 141

Annex 2: Number of enquiries per year received by national helpdesks .................... 143

Annex 3: Forum activities considered most relevant to enhance coordination,

cooperation and exchange of information among Member States ......................... 144


Annex 4: REACH enforcement activities ............................................................... 147

Annex 4.1: Estimate of the total number of dutyholders who are likely to have duties imposed on them by REACH / Estimate of the number of dutyholders

who are likely to be considered as registrants as defined by REACH ............... 147

Annex 4.2: Number of manufacturers subject to enforcement activities ................ 148

Annex 4.3: Number of only representatives subject to enforcement activities ........ 150

Annex 4.4: Number of distributors subject to enforcement activities .................... 151

Annex 4.5: Number of downstream users subject to enforcement activities ........... 153

Annex 4.6: Number of importers subject to enforcement activities ....................... 155

Annex 4.7: Number of REACH controls prompted by complaints or concerns

received by Enforcing Authorities in relation to alleged contraventions of the REACH Regulation ................................................................................... 157

Annex 4.8: Number of REACH controls prompted by incidents (e.g. accidents such

as poisoning or other dangerous occurrences)............................................. 158

Annex 4.9: Number of REACH controls prompted by monitoring activities ............. 159

Annex 4.10: Number of REACH controls prompted by the results of an inspection .. 160

Annex 4.11: Number of REACH controls addressing registration and number of

cases of non-compliance found ................................................................. 161

Annex 4.13: Number of REACH controls addressing registration and notification of

substances in articles and number of cases of non-compliance found ............. 162

Annex 4.14: Number of REACH controls addressing the obligation of information in

the supply chain and number of cases of non-compliance found .................... 163

Annex 4.15: Number of REACH controls addressing the duty to communicate information on substances in articles and number of cases of non-compliance

found .................................................................................................... 164

Annex 4.16: Number of REACH controls addressing restriction and number of cases

of non-compliance found .......................................................................... 165

Annex 4.17: Number of REACH controls addressing authorisation and number of


Annex 4.18: Number of REACH controls addressing imported goods and number of


Annex 4.19: Number of REACH controls in which resulted no areas of infringement was found .............................................................................................. 168

Annex 4.20: Number of REACH controls which resulted in verbal or written advice . 169

Annex 4.21: Number of REACH controls which resulted in legal proceedings ......... 170

Annex 4.22: Number of REACH controls which resulted in convictions .................. 171

Annex 4.23: Number of REACH controls which resulted in other enforcement actions172

Annex 5: CLP enforcement activities ................................................................... 173

Annex 5.1: Total number of official controls, such as inspections or investigations,

or other enforcement measures carried out by enforcing authorities in which

CLP was covered and/or enforced during the reporting period ....................... 174

Annex 5.2: Estimate of the total number of dutyholders who are likely to have

duties imposed on them by CLP ................................................................ 175

Annex 5.3: Number of manufacturers subject to enforcement activities under CLP . 176


Annex 5.4: Number of Distributors subject to enforcement activities under CLP ..... 178

Annex 5.5: Number of downstream users subject to enforcement activities under CLP ...................................................................................................... 180

Annex 5.6: Number of importers subject to enforcement activities under CLP ........ 182

Annex 5.7: Number of CLP controls prompted by complaints or concerns received by enforcing authorities in relation to alleged contraventions of the CLP

Regulation ............................................................................................. 184

Annex 5.8: Number of CLP controls prompted by incidents (e.g. accidents such as

poisoning or other dangerous occurrences)? ............................................... 185

Annex 5.10: Number of CLP controls prompted by Monitoring activities ................ 186

Annex 5.11: Number of CLP controls prompted by the results of an inspection ...... 187

Annex 5.12: Number of CLP controls addressing hazard classification and number of


Annex 5.13: Number of CLP controls addressing hazard communication in the form of labelling and cases of non-compliance found ........................................... 190

Annex 5.14: Number of CLP controls addressing packaging and cases of non-compliance found ................................................................................... 192

Annex 5.15: Number of CLP controls addressing Harmonisation of classification and labelling of substances and cases of non-compliance found ........................... 194

Annex 5.16: Number of CLP controls addressing Notification to the classification and labelling inventory according to Article 40 and cases of non-compliance found . 195

Annex 5.17: Number of CLP controls addressing Other common provisions, such as

the obligation to maintain information and requests for information and cases of non-compliance found .......................................................................... 197

Annex 5.18: Number of CLP controls addressing imported goods and cases of non-compliance found ................................................................................... 198

Annex 5.19: Number of CLP controls addressing other CLP obligations and cases of non-compliance found ............................................................................. 199

Annex 5.20: Number of CLP controls in which no areas of infringement were found 200

Annex 5.21: Number of CLP controls which resulted in verbal or written advice ..... 201

Annex 5.22: Number of CLP controls which resulted in legal proceedings .............. 202

Annex 5.23: Number of CLP controls which resulted in convictions ....................... 203

Annex 5.24: Number of controls which resulted in other enforcement actions ........ 204


ABREVIATION USED

BPR Biocidal Products Regulation

CA Competent Authority

CHESAR Chemical Safety Assessment and Reporting tool

CLEEN Chemicals Legislation European Enforcement Network

CLH Harmonised classification and labelling

CLP Regulation No 1272/2008 on classification, labelling and packaging of

substances and mixtures, amending and repealing Directives

67/548/EEC and 1999/45/EC, and amending Regulation (EC) No

1907/2006

CMR Carcinogenic, mutagenic and toxic for reproduction

CoRAP Community Rolling Action Plan

DAFM Department of Agriculture, Food & the Marine (Ireland)

DECC Department of Energy and Climate Change (United Kingdom)

ECHA European Chemicals Agency

EEA European Economic Area

EPA Environmental Protection Agency

ES Exposure Scenario

EU European Union

FAQ Frequently Asked Questions

FTE Full time equivalent

GHS Globally Harmonised System of Classification and Labelling of Chemicals

HSA Health and Safety Authority (Ireland)

HSE Health and Safety Executive (United Kingdom)

IGAOT General Inspectorate for the Environment and Spatial Planning

(Portugal)

IUCLIDInternational Uniform Chemical Information Database

MSC Member States Committee

NEA National Enforcement Authority

NIEA Northern Ireland Environment Agency

OECD Organisation for Economic Co-operation and Development

OSH Occupational health and safety

PAH Polycyclic aromatic hydrocarbon

PfA Proposal for Amendment

PBT Persistent Bioaccumulative Toxic chemicals

PIC Regulation No 649/2012 concerning the export and import of hazardous

chemicals

POP Persistent organic pollutants

QSAR Quantitative Structure-Activity Relationships

RAC Risk Assessment Committee

RAPEX Rapid Exchange of Information System

REACH Regulation No 1907/2006 concerning the Registration, Evaluation,

Authorisation and Restriction of Chemicals

REF REACH-EN-FORCE

REFT Restriction Efficiency Task Force

RiME Risk Management Expert meeting

RIPE REACH Information Portal for Enforcement

RMOA Risk management option analysis


RNC Risk Communication Network

SAICM Strategic Approach to International Chemicals Management

SEAC Committee for Socio-economic Analysis

SDS Safety data Sheets

SME Small and Medium Enterprise

SONC Statement of non-compliance

SVHC Substance of very high concern

VOC Volatile organic compounds

WEEE Directive 2012/19/EU on waste electrical and electronic equipment

WG Working group


April 2016 I XV

EXECUTIVE SUMMARY

This report provides a comparative analysis of the 2015 Member States reporting

questionnaires under Article 117(1) of the REACH Regulation and Article 46 of the CLP Regulation. Member States are required to submit to the European Commission every

5 years a report on the operation of the REACH Regulation in their respective territories, including sections on evaluation and enforcement (Article 117(1) 117 of the

REACH Regulation) and a report on the results of the official controls, and other enforcement measures taken to ensure compliance with the CLP Regulation (Article 46

of the CLP Regulation).

Competent authorities There are 45 REACH Competent Authorities (CA) operating in the 28 EU Member

States and the 3 EEA countries. 6 countries have more than 1 CA. 28 CAs deal with all REACH processes.

44 CAs indicated they are involved in other chemical legislation. A large majority of

them have responsibilities in CLP (39), biocides (30) and PIC (30). In countries where

only 1 CA has been designated, all CAs except 1 (the Netherlands) have some responsibilities on CLP.

CAs are generally satisfied with their level of technical resources, while they consider

their financial and human resources insufficient or limited, which impedes the achievement of all activities required under REACH.

Cooperation and communication between CAs, and with ECHA and the Commission

CAs generally expressed a high level of satisfaction with the cooperation between CAs

at EU and national levels and with the cooperation with ECHA and the Commission.

National helpdesks

In 25 countries, the REACH helpdesk is part of the REACH CA. In the 6 other cases, the helpdesk is part of another Ministry, a public Agency or a public research institute.

In 24 countries, the REACH helpdesk is also responsible for providing assistance to

industry on CLP.

Helpdesks provide a combination of services ranging from online guidance, advice services, newsletter and/or training. The majority of helpdesks receive between 100

and 1000 enquiries per year. Most enquiries related to registration, safety data sheets and CLP labelling. Only 11 countries keep track of the size of enquirers; in these

countries that have reported data, most enquirers were SMEs.

Awareness raising activities All countries – except Czech Republic and Luxembourg – indicated they have carried

out awareness raising activities during the reporting period. Most countries tend to target a broad audience in their activities (consumers, companies in chemical and

downstream sector). Two-thirds of EU/EEA countries have targeted SMEs as a specific group. Most common awareness raising activities include the production of accessible

information content and the organisation of speaking events.


April 2016 I XVI

Alternative test methods

17 countries indicated they have contributed in the past 5 years to EU and/or OECD work on the development and validation of alternative test methods by participating in

relevant committees.

11 countries provided data on the overall public funding on national research and

development of alternative testing, with 6 countries reporting expenditure of more than Euro 100,000 per year, and 2 countries (Germany and the Netherlands) of more

than Euros 1,000,000.

REACH Commission and ECHA expert groups

CAs expressed a high level of satisfaction towards the functioning of the Forum, the REACH Committee, the Member States Committee (MSC), the Risk Assessment

Committee (RAC) and the Helpnet Committee. The Socio-Economic Assessment

Committee (SEAC), CARACAL and the Risk Communication Network (RCN) gathered less positive feedback. Frequent comments, on all Committees, address organisational

issues and working methods, workload, availability of experts and resources. CAs made suggestions for improvements detailed in Theme 6.

Dossier and substance evaluation

15 CAs reported having been involved in dossier evaluation during the reporting period. Most of them considered that the dossier evaluation process had achieved its

objectives, although some concerns have been raised on the poor quality of registration dossiers impeding the evaluation.

23 CAs have been involved in substance evaluation. 36 substances have been

evaluated in 2012, 47 in 2013 and 51 in 2014. Most frequent issues reported by CAs regarding the substance evaluation process are related to the lack of expertise,

capacity and financial resources, and updates of dossiers by registrants during the

twelve-month evaluation period, leading to changes in the evaluation process.

Restriction and SVHC dossiers

9 CAs indicated having been involved in the preparation of Annex XV Restriction Dossiers during the reporting period, sometimes co-prepared with other CAs or with

ECHA. 7 of them have consulted or involved enterprises in the preparation of restriction dossiers.

11 countries reported having been involved in the preparation of Annex XV SVHC dossiers, sometimes co-prepared with other CAs or with ECHA. 7 of them have

consulted or involved enterprises in the preparation of the dossiers. Most CAs (26) considered there is enough coordination between ECHA and CAs in the implementation

of the SVHC Roadmap.

Enforcement

Enforcement authorities

25 CAs indicated that there was more than 1 REACH national enforcement authority (NEA) in their country; these include environmental authorities, authorities responsible

for health, and consumer protection, chemical agencies, labour inspectorates, and customs administrations.


April 2016 I XVII

21 CAs indicated that there was more than 1 CLP NEA in their country. Although the enforcement of CLP can involve different institutions than those enforcing REACH, in

all EU/EEA countries, the lead enforcement authority is the same for REACH and CLP. In 24 countries, REACH NEAs have responsibilities for enforcing other chemical legal

acts such as the Biocidal Product Regulation or PIC.

Enforcement strategies

The majority of EU/EEA countries (21) indicated having already implemented their enforcement strategy. Strategies can be, depending on the country, stand-alone

REACH enforcement strategies, general strategies not only applied in REACH enforcement, or operational documents planning for enforcement actions. All countries

that devised or implemented an enforcement strategy indicated that it is in line with the strategy of the Forum.

Prioritisation of inspections is usually based on risk analysis. Companies are selected

for inspections according to their potential risk of non-compliance, the risks posed by

the substance and the volume of production, and the type of consumer exposed to the end-product. A number of CAs mentioned aligning their priorities on those defined in

Forum enforcement projects (REACH-EN-FORCE). Among Forum activities, CAs considered enforcement project and pilot projects as the most effective cooperation

activities.

26 CAs indicated having an overall strategy for the enforcement of the CLP Regulation. Over half of them indicated that their strategy was the same as the REACH

enforcement strategy, or described very similar elements to their REACH strategy.

Enforcement activities

All CAs provided data on number of official controls, including inspections, investigations, monitoring, or other enforcement measures related to REACH and CLP.

There is, in both cases, a large degree of variation between countries. Some of the variation may be attributed to the different interpretations of which enforcement

measures should be included or different ways of collecting data. In general, data provided by CAs were often incomplete and not consistent.

Data reported by CAs suggest that, during the reporting period, enforcement activities conducted by NEAs concerned mostly distributors and downstream users, and small

and micro companies. Controls were mostly prompted by monitoring activities and results of previous inspections, rather than by incidents and complaints. In addition, a

higher number of REACH enforcement activities addressed information in the supply chain and restrictions, while CLP controls mostly addressed hazard classification and

labelling. Responses from CAs also show that the majority of controls which identified infringement to the two Regulations are resolved prior to legal proceedings.

Sanctions CAs have described a mixture of civil and criminal measures – according to their legal

system –including among others enforcement notices and injunctions to apply remedial measures; withdrawal of products from the market; administrative fines,

criminal sanctions including fines and imprisonment.

Evaluating the impacts of REACH on the environment, human health, competitiveness and innovation

With the exceptions of Latvia and Slovenia, CAs stated that the effects of REACH would be better evaluated at EU level. 3 CAs felt that evaluating effects was necessary

both at EU and national level.


April 2016 I 18

INTRODUCTION

This report provides a comparative analysis of the 2015 Member States reporting

questionnaires under Article 117 of the REACH Regulation and Article 46 of the CLP

Regulation. Member States are required to submit to the European Commission every 5

years a report on the operation of the REACH Regulation in their respective territories,

including sections on evaluation and enforcement (art. 117 of the REACH Regulation) and

a report on the results of the official controls, and other enforcement measures taken to

ensure compliance with the CLP Regulation (art. 46 of the CLP Regulation).

EU Member States and EEA countries (Iceland, Liechtenstein, and Norway) were asked to

fill in an online questionnaire, using EUsurvey, an internet-based consultation tool. The

questionnaire requested information on a wide range of issues including:

Composition and organisation of the Competent Authority (hereafter abbreviated as

CA);

Co-operation and communication with other Member States, the Agency and the

Commission;

Operation of the national helpdesk;

Awareness-raising activities conducted by CAs

Promotion of alternative test methods

Participation in REACH Commission and ECHA expert groups

Dossier and substance evaluation

Annex XV restriction dossiers and SVHC dossiers

Enforcement of REACH and CLP regulations

The effectiveness of REACH on the protection of health and environment and the

effects of REACH on innovation and competitiveness

EU Member States and EEA countries reported on their enforcement of REACH for the

period 2010-2015 and their enforcement of CLP between 2011 and 2014. The reporting

period for the first CLP report covered the time between the entry into force of the CLP

Regulation (20 January 2009) and the deadline for submission of this report (20 January

2012). However, the data provided by respondents for the year 2011 were not always

fully complete. This is why it was requested again in this report.

This report follows the structure of the questionnaire, and provides an overview of CAs’

responses for each question. Information on enforcement of REACH and CLP has been

combined, as a certain amount of overlap has been identified in CAs’ responses.


April 2016 I 19

1 Theme 1 information on the CA

1.1 Organisation of CA(s) for the operation of REACH

45 CAs have been appointed by EU/EEA countries. 6 countries have appointed more than

1 CA. Only 1 country reported changes in the organisation of CAs since the last reporting

exercise. In Romania, 4 CAs have been nominated between 2011 and 2013: the Ministry

of Health for implementing REACH regarding health aspects, the Ministry of Labour,

Family, Social protection and Elderly for implementing REACH regarding occupational

health and safety (OSH) aspects, the Ministry of Defence for implementing art.2 (3) of

REACH and establishing national procedure for exemptions, and the Labour Inspection as

enforcement CA with regards to OSH.

Table 1: CA(s) responsible for REACH

Country Number of CA(s)

Name(s) of CA(s)

Austria 1 Federal Ministry of Agriculture, Forestry, Environment and Water Management

Belgium 1 Risk Management of Chemical Substances Unit Department of Product Policy and Chemical Substances DG Environment Federal Public Service Health, Food Chain Safety and Environment

Bulgaria 1 Ministry of Environment and Water

Croatia 1 Ministry of Health

Cyprus 1 Department of Labour Inspection, Ministry of Labour,

Welfare and Social Insurance

Czech Republic 3 Ministry of the Environment

Ministry of Health Ministry of Industry and Trade

Denmark 1 Danish Environmental Protection Agency

Estonia 1 Health Board

Finland 1 Finnish Safety and Chemicals Agency

France 1 Ministry of Ecology, Sustainable Development and Energy,

General Directorate for Risk Prevention CLP: General Directorate for Labour of the French Ministry of Minister of Labour, Employment, Vocational Training

and Social Dialogue.

Germany 2 Federal Ministry for the Environment, Nature

Conservation, Building and Nuclear Safety Federal Institute for Occupational Safety and Health

Greece 1 Ministry of Finance, General Secretariat of Public Revenue,

General Chemical State Laboratory, Directorate of Energy, Industry and Chemical Products

Hungary 1 National Public Health Centre

Iceland 1 The Environment Agency of Iceland

Ireland 3 Health and Safety Authority (HSA) Environmental Protection Agency (EPA)

Department of Agriculture, Food & the Marine (DAFM)

Italy 1 Ministry of Health-DG Health Prevention

Latvia 1 Latvian Environment, Geology and Meteorology Centre

Liechtenstein 1 Office of environment

Lithuania 1 Environmental Protection Agency

Luxembourg 1 Ministry of Environment

Malta 1 The Malta Competition and Consumer Affairs Authority

Netherlands 1 Ministry of Infrastructure and the Environment CLP: Ministry of Health, Welfare and Sport


April 2016 I 20

Country Number of CA(s)

Name(s) of CA(s)

Norway 1 Norwegian Environment Agency

Poland 1 Bureau for Chemical Substances

Portugal 3 Portuguese Environment Agency

Directorate-General of Health Directorate General of Economic Activities

Romania 7 Ministry of Environment, Waters and Forests National Environmental Protection Agency

Ministry of Health Ministry of Labour, Family, Social Protection and Elderly Ministry of National Defence

National Environmental Guard Romanian Labour Inspection

Slovakia 1 Centre for Chemical Substances and Preparations, Ministry of Economy

Slovenia 1 Chemicals Office of the Republic of Slovenia

Spain 2 Ministry of Health, Social Services and Equality, General Directorate of Public Health, Quality and Innovation

Ministry of Agriculture, Food and Environment – General Deputy for air quality and the environment

Sweden 1 Swedish Chemicals Agency

United Kingdom 1 The Department for Environment, Food and Rural Affairs

(Defra) is the lead government department for REACH in the UK. Defra has the policy lead for REACH in the UK. The Health and Safety Executive hosts the delegated CA role on behalf of the UK Government.

34 CAs indicated they cooperated with other institutions in relation to REACH issues –

mostly in the areas of environment, consumer protection, employment, health and

safety, public health, economy/industry and customs. In 5 countries, the (main) CA has a

formal role of coordination between other CAs and ministries (Austria, Italy, Lithuania,

the Netherlands, and Spain). In Romania, a working group for the collaboration between

CAs has been established.

In 2 cases, the CAs are assisted by agencies or governmental bodies. In the Netherlands,

the Bureau REACH (National Institute for Public Health and the Environment) carries out

major part of the REACH tasks. In France, the French Agency for Food, Environmental

and Occupational Health & Safety (ANSES) recommends priorities for evaluation,

authorisation and restriction, prepares the French dossiers of proposals of restriction,

identification of substances of very high concern and of harmonised classification and

labelling, prepares opinions to be submitted by the French authorities on the dossiers

proposed by other countries, and participates in the Risk Assessment Committee (RAC)

and Socio-Economic Assessment Committee (SEAC).

Appointed CAs for REACH are mainly environmental, health or consumer protection

authorities. 19 CAs (out of 45) are responsible for or have authority from the Ministry

responsible for Environment. The total number of CAs indicated in Figure 1 is greater

than 45 as 9 CAs indicated that their authority derived from more than one source.


April 2016 I 21

Figure 1: From what part of Government does this part of the CA has authority from? (Question 11)

The Estonian CA has authority from the Ministry responsible for social affairs. In France

and Luxembourg, the CAs have authority from the Ministries responsible for

environment, infrastructures, transports and, in the case of France, energy.

1.2 Competences of CA(s)

28 CAs (out of 45) reported dealing with all REACH processes – evaluation, risk

assessment, registration, restriction, authorisation and helpdesk.

Among the 25 countries which have 1 CA, the authority is responsible for all parts of

REACH in 21 countries. In Belgium, the CA is responsible for all parts of REACH except

the helpdesk, and has additional competences on harmonised classification and labelling

(CLH), nanomaterials, endocrine disruptors, persistent, bioaccumulative and toxic for

reproduction (PBT) substances, read across, REACH and other pieces of legislation. In

Estonia, the CA deals with evaluation; risk assessment; and the helpdesk. In

Luxembourg the CA is responsible for evaluation; risk assessment; restriction and CLP.

Several CAs mentioned they were also responsible for CLP and enforcement. This

information is available in Themes 9 and 10.

In the 6 countries which have more than 1 authorities, the distribution of competence is

as follows:

Table 2: Competences of CAs in countries where there are more than 1 CA

Country Competences of CAs

Czech Republic

The Ministry of Environment is responsible for all parts of REACH The Ministry of health is responsible for risk assessment The Ministry of Industry and Trade is responsible for authorisation and registration

Germany The Ministry of Environment is responsible for evaluation; authorisation restriction The Ministry of Employment has competence in all parts of REACH

Ireland The Health and Safety Authority is responsible for all parts of REACH The Environmental Protection Agency is responsible for authorisation, restriction and

registration The Department of Agriculture, Food & the Marine is responsible for pesticides

Portugal The Environment Agency is responsible for all parts of REACH except the helpdesk

The General Directorate of Health is responsible for all parts of REACH except the helpdesk General Directorate for Economic Activities is responsible for authorisation,

0 5 10 15 20 25

Consumer Protection

Occupational Health and Safety

Other

Economy/Industry

Public health

Environnement


April 2016 I 22

Country Competences of CAs

restriction, registration and the helpdesk

Romania The Ministry of Environment, the National Environmental Protection Agency and the Ministry of Health are responsible for all parts of REACH

The Ministry of Labour is responsible for risk assessment and restriction

Ministry of National Defence deals with exemptions art.2 (3) of REACH where necessary in the interest of defence National Environmental Guard deals with authorisation, restriction, registration and

enforcement Romanian Labour Inspection has competence in authorisation, restriction and enforcement

Spain The Ministry of Health is responsible for all parts of REACH except the helpdesk, and coordinates enforcement

The Ministry of Agriculture has competence in all parts of REACH

44 CAs indicated they are involved in other chemical legislation1. A large majority of

them have responsibilities in CLP (39), biocides (30) and PIC (30). In countries where

only 1 CA has been designated, all CAs except 1 (the Netherlands) have some

responsibilities on CLP2.

Figure 2: What other chemical legislation are the staff of the REACH CA involved in? (Question 16)

Table 3: what other chemical legislation are the staff of the REACH CA involved in? (per country)

Country Chemical legislation

Austria PIC Regulation; Biocides; CLP; Pesticides; POPs; Other

Belgium PIC Regulation; CLP; POPs; Other (Mercury, PIC, Strategic Approach to

International Chemicals Management (SAICM), Nanomaterials, OECD group on chemicals, endocrine disrupters, PBT)

Bulgaria PIC Regulation; Biocides; CLP; POPs; Other (Detergents, Seveso, Mercury Export Ban Regulation, RoHS)

Croatia PIC Regulation; Biocides; CLP

Cyprus PIC Regulation ;CLP; POPs; Other (Control of VOCs in paints)

Czech Republic Ministry of Environment: CLP; POPs

1 In Romania, 1 of the 7 CA – the Ministry of National Defence – indicated that its staff was not involved in other chemical legislation. 2 The CA is the same for REACH and CLP in all countries, with the exception of France and the Netherlands. Although the French Ministry of Labour is the CA for CLP, the Ministry of Environment

(REACH CA) shares some responsibilities on CLP.

0 5 10 15 20 25 30 35 40 45

Food legislation

Medical devices

Workers Protection legislation

Cosmetics

Pesticides

Other

POPs

PIC Regulation

Biocides

CLP


April 2016 I 23


Ministry of health : Biocides; CLP Ministry of Industry and Trade: CLP

Denmark PIC Regulation; Cosmetics; Biocides; CLP; Pesticides; POPs; Other (product

safety, RoHs, toy safety, ozone depleting substance, VOC, national use restriction)

Estonia PIC Regulation; Cosmetics; Medical devices; Biocides; CLP

Finland Cosmetics; CLP; Other (Detergents)

France PIC Regulation; Biocides; CLP; Pesticides; POPs; Other (endocrine disruptors,

nanomaterials)

Germany Ministry of Environment: PIC Regulation; Biocides; Pesticides; POPs

Ministry of Employment: PIC Regulation; Workers Protection legislation; Biocides; CLP; POPs

Greece PIC Regulation; CLP

Hungary PIC Regulation; CLP;POPs

Iceland Cosmetics; Biocides; CLP; Pesticides; POPs; Other (nature and environment legislation)

Ireland Health and Safety Authority: PIC Regulation; Workers Protection legislation; CLP; Other (Detergents, Chemical Agents, Carcinogens/Mutagens, Asbestos,

Seveso, Chemical Weapons, Biological Agents, Dangerous Preparations Directive)

Environmental Protection Agency: POPs; Other (WEEE, batteries, VOC)

Department of Agriculture, Food & the Marine: PIC Regulation; Food legislation; Biocides; CLP; Pesticides; POPs

Italy PIC Regulation; Workers Protection legislation; Biocides; CLP; Pesticides; POPs; Other (Mercury Convention; Detergents; Seveso; End of Waste)

Latvia Biocides; CLP; Other national legislation

Liechtenstein PIC Regulation; Biocides; CLP; Pesticides

Lithuania PIC Regulation; CLP; POPs; Other (National legislation of chemicals; Waste regulation; Exposure assessment of environmental)

Luxembourg PIC Regulation ;Biocides; CLP

Malta PIC Regulation; Cosmetics; Medical devices; Biocides; CLP; Pesticides; POPs

Netherlands PIC Regulation; Biocides; Pesticides; POPs

Norway Biocides; CLP; POPs; Other (Mercury Convention, Stockholm Convention, Transboundary air pollution, International Chemical Management, OECD groups on chemicals, REACH, Biocides, GHS, Product Registers, Enforcement, Exposure, Test methods - OSPAR Hazardous Chemicals Group)

Poland PIC Regulation; Workers Protection legislation; Cosmetics; Biocides; CLP; Pesticides; POPs; Other (Detergents, Good Laboratory Practice, Drug Precursors

regulation, Tobacco Products, safety of toys, explosives precursors, GHS)

Portugal Environment Agency: PIC Regulation; Biocides; CLP

General Directorate of Health: Biocides; CLP General Directorate for Economic Activities: CLP; Other (Dangerous

Preparations; Aerosols)

Romania Ministry of Environment: PIC Regulation; Biocides; CLP; Other (Detergents) National Environmental Protection Agency: PIC Regulation; Biocides; CLP;

Pesticides; POPs

Ministry of Health: Food legislation; Workers Protection legislation; Cosmetics; Medical devices; Biocides; CLP; Pesticides

The Ministry of Labour: PIC Regulation; Workers Protection legislation; Other

(explosives for civil uses, pyrotechnic articles) National Environmental Guard : PIC Regulation; Biocides; CLP; Pesticides;

POPs; Other (Waste management, Seveso, Market Surveillance, Mercury,

Asbestos, F-Gases, ODS, Detergents, Fertilisers, PCB, Environment legislation)

Slovakia Biocides; CLP; Other (Detergents, aerosol dispensers)

Slovenia PIC Regulation; Cosmetics; Biocides; CLP; POPs; Other (Detergents, Chemical Weapon Convention)

Spain Ministry of Health: CLP Ministry of Agriculture: PIC Regulation; Biocides; CLP; Pesticides; POPs


April 2016 I 24


Sweden PIC Regulation ;Biocides; CLP; Pesticides; POPs; Other (Toys directive, RoHS directive, VOC directive, detergents regulation)

United Kingdom PIC Regulation; Biocides; CLP; Pesticides

1.3 Human resources

Table 4 presents the number of staff of the CAs. CAs have reported their staff differently

– number of staff or FTEs. It can be assumed that numbers of staff reported include staff

members working only part-time on REACH. CAs resources vary greatly across countries,

from 1 staff in Liechtenstein to 43 in Italy.

Table 4: Number of staff in CA(s)

Country Number of staff in CA(s)

Austria 20

Belgium 12

Bulgaria 8

Croatia 4

Cyprus 4.5

Czech Republic 3 in the Ministry of Environment; 1 in the Ministry of Health; 2 in the ministry of Industry and Trade

Denmark 20

Estonia 9

Finland 15

France 4.5

Germany 5 in the Ministry of Environment; 30 in the Federal Institute for Occupational Safety and Health

Greece 11

Hungary3 9

Iceland 0.2

Ireland 7.5 FTE in the Health and Safety Authority; 0.2 FTE in the EPA. In addition, there are 27 staff in the Pesticide Registration and Control Divisions (DAFM) whose work may include aspects that cover the

implementation of REACH.

Italy 43

Latvia 4

Liechtenstein 1

Lithuania4 14

Luxembourg5 4

Malta 2

Netherlands 4.5 FTE

Norway 16

Poland 19 FTE

Portugal 5 in the EPA; 3 in the Directorate-General of Health; 4 in the Directorate-General of Economic Activities

Romania 1 in the Ministry of Environment; 3 in the National Environmental Protection Agency; 4 in the ministry of Health; 1 in the ministry of Labour;

2 in the Ministry of National Defence / 204 in the National Environmental Guard; 104 in the Labour Inspection

Slovakia 7

Slovenia 4

Spain 8 in the Ministry of Health, Social Services and Equality; 4 in the Ministry

3 The CA staff includes staff of the REACH Helpdesk, who are involved in the work of the CA when necessary. 4 The number of staff in the Lithuanian Environmental Protection Agency gradually increased from 4 (in 2010) to 14 in the reporting period. 5 The number of staff in Luxembourg increased from 1 to 4 over the reporting period.


April 2016 I 25

Country Number of staff in CA(s)

of Agriculture, Food and Environment

Sweden 13

United Kingdom 24

Figure 3 presents the staff skills available to all respondent CAs. A large share of CAs

have chemistry expertise – although 10 CAs indicated not having such skills. A significant

proportion lacks exposure assessment and risk assessment skills. However ‘economics

skills’ is the type of skills that CAs most commonly lack – 36 CAs indicated they not

having these skills in-house.

Figure 3: Skills available in CA(S)

Other staff available includes legal advisors (Italy, Sweden), biologist and biomedicine

specialists (Lithuania), biologists (Luxembourg), statisticians (Italy), physicists (Italy),

environment specialist (Latvia).

Most CAs (28 in 20 countries) are satisfied with their in-house level of expertise. CAs

identified a lack of expertise in socio-economic analysis (Belgium, Spain), chemistry and

ecotoxicology (Irish HSA), specific endpoints in toxicology and specific expertise such as

epidemiology (Belgium), evaluation (Romanian EPA), risk communication (Belgium),

exposure assessment, risk assessment and management in particular for endocrine

disruptors (Portuguese EPA). 2 authorities indicated that due to resources constraints,

they have limited specialised staff (Irish HSA and Spain), which in certain cases, reduces

capacity for conducting additional activities such as risk management option analysis

(RMOA) or Annex XV dossier preparation (Estonia).

0

5

10

15

20

25

30

35

40

Nu

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Co

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eten

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uth

ori

ties

0 0-3 4-6 > 6


April 2016 I 26

Figure 4: Is the level of expertise of the CA adequate to deal with all requirements under REACH? (Question 14) 6

18 CAs – in 17 countries – indicated that they outsourced part of their work related to

REACH.

Figure 5: EU/EEA countries where at least 1 CA outsources part of its work

Most CAs outsourced scientific expertise to fulfil their duties under REACH during the

reporting period. 5 CAs indicated they outsourced work related to substance evaluation

(Czech Republic, Irish HSA, Latvia, Poland, Portuguese EPA); 1 to restriction dossiers

(Poland)7. 2 CAs mentioned they contracted external expert for the RAC and SEAC work

(Austria and Cyprus). The Irish EPA contracts external to carry-out follow-up inspections

for RAPEX notifications relating to infringement of the REACH Regulation posing a serious

environmental risk. 5 CAs outsourced expertise to research institutes (Hungary, Norway,

Poland, Portuguese EPA, and Slovakia) and 3 to governmental bodies (Denmark,

Slovenia, and the United Kingdom). 2 countries indicated they also contracted private

consultants (the Netherlands and Portuguese EPA) to complete diverse tasks – in

Portugal related to substance evaluation and risk assessment.

6 In Ireland, the HSA and the EPA responded ‘no’ and the department of Agriculture responded ‘yes’; In Romania, 4 CAs out of 7 responded ‘no’. 7 Other CAs have mentioned outsourcing tasks related to substance evaluation and restriction

dossiers (see Table 19 and Table 25)

AT, CZ, DK, EE, FI, FR, DE, EL,

HU, IT, LV, LI, LT, LU, NL, NO, PL,

ES, SE, UK

BE, BG, HR, CY, IS, IE, MT, PT,

RO, SK, SI

Yes No

AT, BE, CY, CZ, DK, HU, IE, LV, NL,

NO, PL, PT, RO, SK, SI, ES,

UK

BG, EE, HR, FI, FR, DE, EL, IS, IT, LI, LT, LU,

MT, SE

Yes No


April 2016 I 27

Table 5: Expertise outsourced by the CA(s)

Country Expertise outsourced by the CA

Austria Toxicology, risk Assessment, exposure (OSH)

Belgium Specific fields of (eco)toxicology, risk management, endocrine disruptor,

market study

Cyprus Scientific expertise

Czech Republic Substance evaluation in CoRAP

Denmark Toxicological assessments

Ireland (HSA) Environmental exposure assessment, environmental hazard assessment,

physical-chemical hazard assessment, inhalatory toxicology expertise

Ireland (EPA) Follow-up inspections for RAPEX notifications relating to contraventions of the REACH Regulation posing a serious enviornmental risk

Hungary Toxicology, IT expertise

Latvia Toxicologist; ecotoxicologist; occupational safety

Netherlands Methodology development, screening activities, cost analysis, analysis of

alternatives and preparation of classification dossiers

Norway Specific scientific expertise in health and environment

Poland Health, economy, labour and environment issues in the process of substance evaluation; or in the process of data collection in restriction

dossiers

Portugal (EPA) Substance evaluation; risk assessment

Romania (National Environmental Guard)

IT services

Slovenia Toxicology; ecotoxicology

Spain (Ministry of

Agriculture)

Helpdesk

United Kingdom Environmental protection, Ecotoxicology

1.4 Financial and technical resources

CAs are generally satisfied with their level of technical resources. Over half of the CAs

considered that their technical resources are ‘high’. The other half of CAs indicated that

their technical resources are ‘medium’ to ‘low’, which is however largely due to the large

number of Portuguese (3) and Romanian (6) CAs that have expressed a lower level of

satisfaction with their technical resources.

With the notable exception of the UK Health and Safety Executive – ranking their

financial and human resources ‘very high’ – the level of satisfaction of CA with their

financial and human resources is significantly lower. 27 CAs consider their financial

resources ‘low’ to ‘very low’ and 24 their human resources ‘low’ to ‘very low’. Although

the same statistical effect as for technical resources also exist here, it is less significant.


April 2016 I 28

Figure 6: CAs’ rating of their financial technical and human resources

Table 6: CAs’ rating of their financial, technical and human resources (per country)

8

Country Financial resources Technical resources Human resources Austria Belgium Bulgaria Croatia Cyprus Czech Republic Denmark Estonia Finland France Germany Greece Hungary Iceland Ireland Italy Latvia Liechtenstein Lithuania Luxembourg Malta Netherlands Norway Poland

8 For countries which have more than 1 authority, the rating is calculated as the median rating for

all CAs.

7

8

17

11

19

12

10

17

8

24

1

1

0 5 10 15 20 25 30 35 40 45

Human resources

Technical resources

Financial resources

Number of Competent Authorities

Very low Low Medium High Very high


April 2016 I 29

Country Financial resources Technical resources Human resources

Portugal Romania Slovakia Slovenia Spain Sweden United Kingdom

Very low Low Medium High Very

High

After rating their financial, technical and human resources, CAs had the possibility to

comment on their responses. Among the 25 countries that have 1 CA, 12 provided a

comment. In addition, 2 CAs in Spain (Ministry of Health and Ministry of Agriculture) and

1 in Romania (National Environmental Guard) provided comments. 9 of them point out

that the lack of resources impedes the achievement of all activities required under

REACH.


April 2016 I 30

2 Theme 2: Information on cooperation and

communication with other Member States, the

European Chemicals Agency (ECHA) and the

Commission

2.1 Communication and collaboration between Member States

10 respondents expressed satisfaction with the existing collaboration and

communication. (Cyprus, Germany, the Netherlands, Lithuania, Spain, Austria, Denmark,

Bulgaria, Ireland, and Belgium) Many also specifically mentioned that communication

through specific expert groups such as RiME or RIPE had been valuable (Sweden, Cyprus,

and Denmark), and that formal communication channels are functioning well. A number

of respondents felt, however, that the current situation still has room for improvement

(especially Poland). Among most respondents there was also a general wish to promote

further collaboration (e.g. Cyprus, Poland, Portugal, or Croatia). Many expressed a need

for informal communication channels (Finland and Hungary), a facilitated use of IT tools

and online discussion (Latvia, Luxembourg), and for an up-to-date list of contact points

within the CA, (Finland, Poland, the United Kingdom, Hungary, Estonia, Portugal, and

France) in order to facilitate communication between the national CAs. There were also 6

comments calling for more concrete collaboration in the form of joint projects or

laboratory contracts, with a particular regard to the circumstances of small countries

which would benefit from the pooling of resources and expertise (Germany, Iceland,

Slovakia, Estonia, Portugal, and Romania).

2.2 Collaboration between authorities at national level

A large number of respondents perceived the existing collaboration with agencies at the

national level as good. (Sweden, Finland, Norway, Lithuania, Poland, the Netherlands,

the United Kingdom, Austria, Denmark, Croatia, Romania, and France) A number of very

different suggestions for further improvement were mentioned, such as EU-level

harmonisation of procedures, using CAS numbers in the Customs database, granting the

CA access to certain databases used by national enforcement authorities, and joint

trainings. Simply having more regular meetings was also considered as beneficial by 3

CAs (Hungary, Estonia, and Latvia), but at the same time 3 other CAs felt that the

capacity to make further improvements is affected by resource allocation and limited

resources (Portugal, Croatia, and Romania).

2.3 Communication and collaboration with ECHA

15 respondents indicated that the communication and collaboration with ECHA is working

well. (Cyprus, Norway, Greece, Lithuania, Spain, the Netherlands, Slovakia, the United

Kingdom, Austria, Croatia, Italy, Malta, Latvia, Slovenia, and France) Suggestions for

further improvements focused, in particular, on ensuring timely, clear and unambiguous

email communication with ECHA, (Sweden, Poland, Ireland, and Belgium) as well as

identifying specific contact points within ECHA for various issues of interest and/or for

different countries. (Finland, Poland, Spain, Hungary, and Portugal)


April 2016 I 31

2.4 Communication between Member States and the Commission

Many respondents expressed satisfaction with the existing communication between the

Commission and the CAs (Cyprus, Norway, Lithuania, Slovakia, Austria, Denmark, Italy,

Latvia, and France). At the same time, 2 CAs wished for more and earlier involvement of

the CAs in the policy activities of the Commission (Germany and Spain). There was a

reoccurring request for the Commission to send information and documents sufficiently

far in advance of the contact group meetings (Sweden, Poland, Hungary, Denmark,

Bulgaria, Portugal, Croatia, and Belgium). 3 also suggested that more time dedicated to

meetings and discussion, or allocating some time for pre-discussion prior to meetings,

would be useful (Portugal, Romania, and Italy). 2 respondents suggested that the

Commission should engage in closer cooperation with the individual countries by making

country visits or organising joint events at the national level (Romania and Malta).


April 2016 I 32

3 Theme 3: Operation of the national helpdesk

3.1 Structure of the helpdesk

In the majority of EU/EEA countries (25), the REACH helpdesk is part of the CA. In the 6

other countries, it can be part of a Ministry – which is not the CA (Belgium and Italy), a

public Agency (Austria and Czech Republic) or public research institute (Luxembourg and

France).

Figure 7: Institutional structure of the Helpdesk in EU/EEA countries

Table 7: Helpdesks separated from the CA

Country Helpdesk

Austria Federal Environment Agency

Belgium Federal Public Service Economy, SMEs, Self-employed and Energy

Czech Republic Czech Environmental Information Agency (CENIA)

France National Institute for Industrial Environment and Risks (INERIS)

Italy Ministry for Economic Development

Luxembourg Luxembourg Institute of Science and Technology

The REACH helpdesk is generally also responsible for providing assistance to industry on

CLP. Ireland and Norway indicated having recently merged the helpdesks for REACH and

CLP to increase the efficiency of the helpdesk (see below).

BG, HR, CY, DK, EE, FI, DE, EL, HU, IS, IE, LV, LI, LT, MT, NL, NO, PL, PT, RO, SK, SI, ES, SE, UK

AT, BE, FR CZ, IT, LU

0 5 10 15 20 25 30

1

Part of Competent Authority Separate independent entity(ies) Other


April 2016 I 33

Figure 8: Is the same helpdesk used to provide help to industry on CLP? (Question 38)

3.2 Staff and financing of the helpdesk

Figure 9 presents the skills available in EU/EEA countries’ helpdesks. Figures provided by

respondents suggest that some countries might have provided number of staff instead of

FTEs, which could distort the results. Figure 9 shows that most helpdesks have in general

few specialised staff available – apart from chemists, which is the most common

expertise available in helpdesks.

Figure 9: Skills available in helpdesks (FTE)

Other staff includes statisticians (Italy), biomedicine and environment specialists

(Lithuania).

28 helpdesks considered that their level of expertise adequate to respond to all enquiries.

Only 3 helpdesks reported that some expertise is missing (Czech Republic, Ireland, and

Portugal). Czech Republic indicated that the Helpdesk cooperated with experts from the

Ministry of the Environment to compensate gaps. Portugal mentioned legal aspects, IT

tools, and exposure scenarios as missing expertise, and Ireland expertise in chemistry for

substance identification or chemistry specific queries.

AT, BG, HR, CZ, EE, FI, FR, DE,

EL, IS, IE, LV, LI, LT, LU, MT, NO, PL, PT, SK, SI, ES,

SE, UK

BE, CY, DK, IT, HU, NL, RO

Yes No

18 19

5

19 20

26 25 26

21

17

8 10

17

10 9

4 4 4

9 8

2 0 4 1 1 1 2 2 1 4 3 0

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30

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0 0 to 1 1 to 2 > 2


April 2016 I 34

Helpdesks mainly referred enquirers to the ECHA helpdesk for enquiries regarding IT

issues, in particular concerning REACH-IT, IUCLID 5 and CHESAR – 19 helpdesks

mentioned at least 1 of the 3 software or ‘technical IT issues’. 7 helpdesks mentioned

referring to ECHA enquiries from companies based outside the EU (Estonia, Germany,

Hungary, Lithuania, Luxembourg, and Slovakia) or in other EU/EEA countries (Denmark).

Regarding financial resources, only Croatia mentioned that the helpdesk received non-

governmental support.

3.3 Services offered by the helpdesk

All helpdesks have a website, except the helpdesk from Liechtenstein, which provides

support upon request by email. A large number of helpdesks provide a combination of

website, advice services, newsletter and/or training. 5 helpdesks also organise face-to-

face meetings with companies when necessary (Cyprus, Germany, Poland, Slovakia, and

Slovenia) or regular meetings with industry representatives (Belgium). Italy has

established an online support tool for Authorisation and Scaling.

Figure 10: Services offered by the helpdesk

The majority of helpdesks provide at least some of their services (advice services,

training) in English, in addition to their national language. 7 helpdesks (including the

United Kingdom and Ireland) only indicated their national language as working language.

About two-thirds of national REACH helpdesks have provided specific advice to SMEs. 2

of these mentioned that since most of the companies in their country (Finland and

Denmark) were SMEs, they were de facto providing assistance to SMEs, without

specifying how their assistance was adapted to their needs.

0 5 10 15 20 25 30 35

Mediation / conflict resolution

Other

Newsletter

Training

Advice services

Website

Number of Countries


April 2016 I 35

Figure 11: Do you provide specific advice to SMEs? (Question 44)

Helpdesks were then invited to specify how they were adapting their services to SMEs. 7

helpdesks indicated they have created or tailored written materials (website, leaflet,

newsletter) to be more user-friendly, easy to read and adapted to the specific needs of

SMEs, and 8 have set up specific workshops, seminars or training sessions for SMEs. In

France and Germany, specific actions have been planned in view of the REACH

registration deadline. The German helpdesk has for example produced a ‘Guide to

registration under REACH in 2018’. 2 helpdesks have also provided tools such as a search

engine to find how chemical substances are regulated (Norway) or check-list for

consultants, and templates for letter to supplier/customers for SVHC in articles (France).

6 helpdesks mentioned adapting their answers to SMEs (Austria, Germany, Hungary,

Liechtenstein, the Netherlands, and Spain), to make them ‘more concrete’ (Spain) or

specific. For example, the Hungarian helpdesk draws the attention of the enquirer to

SME-related specificities of REACH (reduced fees, necessity of SME-validation) when

answering enquiries. 5 helpdesk organise face-to-face meetings with SMEs on a need

basis (Austria, Bulgaria, Cyprus, Estonia, and Malta).

3.4 Quality assurance

Helpdesks were asked to describe the helpdesk quality assurance mechanisms. The

ISO9001 standard (setting out the requirements of a quality management system) is in

place in 9 helpdesks. In addition, the Lithuanian Environmental Protection Agency is

currently preparing for the implementation of this standard. 8 helpdesks have explicitly

indicated applying internal quality standards, or standard operating procedures for

responding to enquiries (Finland, Greece, Ireland, Italy, Lithuania, Luxembourg, Poland,

Spain) in replacement or in addition to the ISO standard.

AT, BG, HR, CY, DK, EE, FI, FR, DE, HU, IT, LV, LI, LU, ML,

NL, NO, ES, SE

BE, CZ, EL, IS, IE, LT, PL, PT, RO, SK,

SI, UK

Yes No


April 2016 I 36

Figure 12: Is ISO9000 norm in place? (Question 41)

13 helpdesks referred to a quality assurance scheme comparable to the four-eye

principle - 2 individuals approve an answer before it can be sent – or peer review,

involving in particular senior members of the helpdesk, experts, or in-house lawyers. In 4

cases, helpdesks have mentioned cooperating with the CA, either to seek feedback from

experts, or to check the helpdesk’s responses (Czech Republic, Finland, the Netherlands,

and the United Kingdom). In the Netherlands, all helpdesk’s responses are checked by

the National Coordinator for quality and consistency. A small number of helpdesks have

made an explicit reference to ECHA guidelines and FAQs (Greece, Iceland, and Slovakia)

and to HelpEx (Iceland and Ireland). 2 helpdesks referred to customer surveys or

surveys after events as main quality assurance mechanism (Bulgaria and Estonia) or

additional source of information (Italy).

14 countries indicated that the national helpdesk seeks feedback on its performance

(Austria, Belgium, Bulgaria, Czech Republic, Denmark, Estonia, Finland, France,

Germany, Greece, Italy, Lithuania, Luxembourg, and the Netherlands). Helpdesks have

collected feedback from customers through surveys (Czech Republic, Finland, France,

Greece, Italy, and Lithuania), feedback questionnaires distributed at events (Bulgaria,

France, Germany, Lithuania, Luxembourg) meetings with customers’ representatives

(Finland and the Netherlands), and ad-hoc feedback received through emails (Denmark,

Germany).

25 countries indicated that the national helpdesk reviews its performance and consider

ways to improve its effectiveness (all respondents except Iceland, Liechtenstein, Malta,

Poland, Romania and Slovenia). Measures taken to improve effectiveness generally aim

at increasing the visibility and accessibility of the helpdesk, improving communication

with customers and increase efficiency of internal organisation, especially regarding

response delay. Respondents provided the following examples:

Creating standard responses for common issues and questions to reduce response

delay (Belgium and the United Kingdom);

Creating questions databases / IT tools to improve sorting requests and searching

through questions (Ireland, Sweden)

Introduction of webpage to receive questions and send responses (Slovakia)

Merging the REACH and CLP helpdesks to create a single point of contact for

customers (Ireland and Norway);

Improve websites, factsheets, guidance and communication material to reduce the

number of requests (Austria, Germany, Greece, Norway)

HR, DK, FR, IS, LV, LU, MT, NL, NO, ES,

SE AT, BE, BG, CZ, CY, EE, FI, DE, EL, HU,

IE, IT, LI, LT, PL, PT, RO, SK, SI, UK

Yes No


April 2016 I 37

Focus activities on topics where there is high demand (Germany)

Training staff on specific issues related to REACH and CLP Regulations (Greece)

3.5 Number of enquiries received by national helpdesks per year

The number of enquiries received by national helpdesks varies significantly between

countries. France, Germany, Poland, Sweden and the United Kingdom received over a

thousand enquiries per year; Iceland, Liechtenstein and Slovakia (in the last 3 years)

received less than a hundred requests per year.

Figure 13: How many enquiries does the helpdesk receive per year? (Question 42)

The number of enquiries received by national helpdesks has remained relatively constant

over the reporting period in most countries. Greece has however experienced a

significant increase in the number of enquiries received from 2010 to 2014 (from 1-100

in 2010 to over a thousand in 2014). Answers per countries are available in Annex 2.

Communication between companies and helpdesks is essentially done via emails and

phone.

Figure 14: How are the majority of enquiries received? (Question 43)

All countries except Luxembourg and Poland provided data on the percentage of helpdesk

enquiries related to a closed list of topics proposed in the questionnaire. Figure 15

presents the percentage of enquiries received on average by national helpdesks for each

0

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1 - 100 101 - 1000 > 1000

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Number of enquiries recieved per year

0 5 10 15 20 25 30 35

Fax

Letter

Other

Phone

Email

Number of Countries


April 2016 I 38

topic. Cases where helpdesks reported 0% of enquiries received were included in the

average.3 countries whose total percentage of enquiries exceeded significantly 100%

were excluded from the series (Ireland, Malta and Slovenia)9. Greatest number of

enquiries related to registration, safety data sheets and CLP labelling.

Figure 15: Average percentages of enquiries received by national helpdesks on specific topics in the reporting period

Only a third of national helpdesks have kept track of the size of enquirers. Among these,

with the exception of France, large enterprises are generally responsible for a small share

of enquiries, compared to SMEs and micro enterprises. Helpdesks have reported

receiving a higher percentage of enquiries from SMEs. In Cyprus and Estonia, micro-

enterprises sent 90% of enquiries.

Table 8: Company size of enquirers (percentage of total)

Country Large

enterprises

Medium

enterprises

Small

enterprises

Micro

enterprises

Other

Belgium 80-90 80-90

Bulgaria 19.1 23.6 34.83 11.24 11.24

Cyprus 1 1 8 90 0

Estonia 1 2 6 90 1

France 37.3 17.5 24.8 16.4

Greece 12 23 44 21 0

9 Estonia was not excluded although the numbers reported totalled 104.5%.

0 2 4 6 8 10 12 14 16 18 20

Evaluation

Testing

Data sharing

CSR preparation

IUCLID5

SIEFs

REACH-IT

Only representative obligations

Authorisation

Enforcement

CLP Classification and labelling inventory

SVHC

Restriction

CLP Packaging

Obligations regarding articles

Pre-registration

CLP Classification

Downstream user obligations

Other

CLP Labelling

Safety Data Sheets

Registration

Percentage of enquiries recieved


April 2016 I 39

Country Large enterprises

Medium enterprises

Small enterprises

Micro enterprises

Other

Italy 15 20 30 30 5

Malta 10 40 25 25

Netherlands 10 25 25 30 10

Norway 5 35 30 10 20

Slovenia 10 75 5 5 5 Cells were left blank when data were not available.

About half of the helpdesks indicated they received mostly straightforward enquiries, and

the other half, mostly complex enquiries.

Figure 16: Are enquiries received mostly: complex, straightforward, no information?

As shown in Table 9, 7 helpdesks reported receiving at least 70% of complex enquiries.

The perceived complexity of the enquiries received might be related to the fact that 4

these countries reported a limited number of staff available (Austria, Denmark, Ireland,

and Liechtenstein) which suggests a higher workload and potential resources constraints.

Table 9: Proportion of enquiries received considered as ‘complex’ or ‘straightforward’ (percentage)

Country Straightforward Complex

Austria 15 85

Belgium 50 50

Bulgaria 90 10

Croatia 35 65

Cyprus 90 10

Czech Republic 33 67

Denmark 15 85

Estonia 5 95

Finland 95 5

France 40 60

Germany 13 87

Greece 80 20

Hungary 55 45

Iceland 90 10

Ireland 30 70

Italy 60 40

Latvia 65 35

Liechtenstein 30 70

Luxembourg 30 70

Malta 90 10

AT, BE, HR, CZ, DK, EE, DE, FR,

IE, LI, LU, NL, PT, SK, SI, ES

BG, CY, FI, EL, HU, IS, IT, LV,

MT, NO, PL, RO, SE, UK

LT

Complex Straightforward No information


April 2016 I 40

Country Straightforward Complex

Netherlands 40 60

Norway 80 20

Poland 50 50

Portugal 45 55

Romania 75 25

Slovakia 40 60

Slovenia 50 50

Spain 40 60

Sweden 80 20

United Kingdom 60 40

According to helpdesks, a straightforward enquiry requires, on average, 2 days of work

and a complex enquiry about a week and a half.

Figure 17: How long, on average, does it take to respond to the following types of questions? (Question 49)

11 countries indicated they outsourced a number of enquiries (Belgium, Croatia,

Denmark, Estonia, France, Italy, Latvia, Liechtenstein, Lithuania, the Netherlands, and

Norway). They tend to outsource enquiries related to CLP, IUCLID5 and REACH-IT. Other

types of enquiries outsourced are related to workers’ exposure (Norway), physical-

chemical testing (France and Norway), and enquiries from foreign companies (the

Netherlands).

7

1

12

3

7

15

3

7

1

3 1

0 5 10 15 20 25 30

Complex questions

Straightforward questions

4 hours 1 day 3 days 1 week 2 weeks > 2 weeks No information


April 2016 I 41

Figure 18: Types of enquiries outsourced by EU/EEA countries

3.6 Cooperation between helpdesks

20 helpdesks provided an opinion regarding the improvement of the cooperation between

helpdesks under HelpNet. 11 indicated that the current forms of cooperation were

appropriate, or had improved. The level of satisfaction is however higher for HelpNet

meetings than for HelpEx. 2 helpdesks have suggested that HelpEx was not user friendly,

mixing too much information (REACH, CLP and Biocides). 3 helpdesks have however

underlined the effectiveness of working groups under the HelpNet Steering Group and 5

have called for reinforcing them.

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