RMC Meeting Presentation
Geoffroy Tillieux & Patrick de Kort
WELCOME & REMINDER COMPETITION
LAW
2
APPROVAL OF DRAFT AGENDA AND
MINUTES
3
TITANIUM DIOXIDE
Update
4
The issue
TIO2 proposed by ANSES (French Competent Authority) to be classified as a Carcinogen 1b by inhalation
Does not distinguish between nano and non nano forms
Arguments contra:
Based on few more than 20 years old studies in rat exposed to extremely high dust concentrations (250mg/m³)
After reclassification of rat studies only one showed malign tumor, all other were reclassified as benign
Mechanism: lung overload? Effect would be unique to rats and not transferable to humans
Past monitoring of 24,000 workers in 18 TIO2 manufacturing sites over decade do not show adverse respiratory or other health effect
5
The Harmonized Classification Process
ANSES Prepared Harmonised Classification
proposal and submitted
this to ECHA.
European Commission’s REACH Committee decides on the Proposed Classification
ECHA’s Risk Assessment Committee develops Opinion
45 Days Public Consultation
Member State Submits Proposal to ECHA
6
The Harmonized Classification Process
Public Consultation ran from 31May 2016 till 15 July
2016
EuPC and MedPharmPlast
Europe Submitted a
position paper to this
consultation
European Commission’s REACH Committee decides on the Proposed Classification
ECHA’s Risk Assessment Committee develops Opinion
45 Days Public Consultation
Member State Submits Proposal to ECHA
7
The Harmonized Classification Process
ECHA Risk Assessment Committee has 18 months
to develop opinion.
TiO2 should therefore be
done by Nov. 2017
European Commission’s REACH Committee decides on the Proposed Classification
ECHA’s Risk Assessment Committee develops Opinion
45 Days Public Consultation
Member State Submits Proposal to ECHA
8
The Harmonized Classification Process
EC REACH Committee consists of delegates from the 28 Member States
The REACH Committee votes according to examination procedure, meaning:
Positive votes representing 65% of the EU population needs to support the proposal*.
i.e. Blocking minority means a support of MS representing 35% of the EU population
European Commission’s REACH Committee decides on the Proposed Classification
ECHA’s Risk Assessment Committee develops Opinion
45 Days Public Consultation
Member State Submits Proposal to ECHA
9
Potential impact for plastics
industry
In principle only on workers protection for plastics since plastics are articles and TIO2 is authorized in the Food
contact materials positive list
BUT
Risk of substance being eventually proposed as Substance of
Very High Concern (candidate list, authorization)
Potential legal uncertainty in some applications fields (e.g.
medical application packaging)
Unpredictable reaction from market
10
EuPC follows the issue EuPC/PCE Team:
Geoffroy Tillieux , Director technical department coordinating
Martin Policar: follow-up of advocacy
Patrick de Kort: technical issues
General updates via Raw Materials Committee
EuPC TIO2 Expert Group
having a telcon every 1 to 2 months
Gathering technical input
Preparing advocacy material
EuPC TIO2 Advocacy Group
Telcon on a quartely basis
Implementing advocacy at National level
11
EuPC Response
Developed an analysis of alternatives
Preformed a risk assessment based on dust levels
Contributed to the TDMA Socio-Economic Analysis
12
Industry Response
EuPC (and its sector group MedPharmPlast Europe) developed position papers on the classification
EuPC took active role in the industry consortium TDMA/TDIC in developing the Socio-Economic Impact Assessment Final SEA report finalized (not to be widely distributed)
EuPC took action within the TDMA advocacy group to reach out to Member States Competent Authorities to disseminate our knowledge on TiO2
13
Advocacy activities
Liaison with other industries:
Joint value chain EU platform coordinated by TDMA/TDIC including EuPC, CEPE (paints), cosmetics, inorganics, CEFIC, and others
EuPC had meetings with Member State Competent Authorities (Health, Industry, Economy):
Italy
Spain
Germany
France
14
ECHA RAC
First discussion on TiO2 too place on 14 March 2017
The Committee familiarized themselves with the key issues of the dossier
The rapporteur presented that RAC should look at the form of the substance rather than its chemical composition
RAC aggreed that any classification for TiO2 could not lead to a general classification for other similar PSLT (poorly soluble low toxicity) substances
Substances to be tackled one at a time
15
ECHA RAC
RAC Chairman indicated that weight of evidence approach should be taken, including epidemiological studies being taken into account
RAC will continue their discussion at the June 2017 meeting
Studies on animals will be analyzed
Further discussion to take place at the September 2017 meeting
Relevance to humans to be assessed
RAC Opinion, therefore, expected not earler than at the September meeting
16
Next ECHA RAC meetings
17
RAC-41
Tentative: 29 May - 2 June and 5 - 9 June 2017 (if needed)
Helsinki
RAC-42 Tentative: 4 - 8 September and 18 - 22 September 2017 (if needed)
Helsinki
RAC-43 27 November - 1 December and
4 - 8 December 2017 (if needed)
Note: 6 December Finnish Independency Day 100 year - no meeting on this day
Helsinki
Socio-economic Impact Assessment
Final version has been made available by RPA
Not to be published publicly
Specific information from the study to be used in a
targeted way in presentations and discussions
Executive summary and presentation with key findings to
be prepared by TDMA
18
Board of Appeal Verdict on Substance
Identification European TiO2 producers won their appeal against an ECHA dossier
compliance Decision
← ECHA asked them to give detailed information about the substance's nanoform as part of the information required on substance identity.
Board of Appeal decided that the provision of the EU law is clear and precise and could not be interpreted by the agency to require the detailed substance information
BoA recognized that the information on the hazards of a substance's nanoform should be addressed by the scientific information provided in a registration dossier
However, the agency cannot demand such information on the grounds that the dossier fails to provide enough information on substance identity
19
Exposure scenarion study TDMA will launch an exposure scenario study looking at life cycle
of the substance including:
(i) manufacture
(ii) formulation
(iii) industrial or professional end-uses, as well as consumer use
will engage with the downstream user Trade Associations in this review
waste life cycle stage (e.g. exposure to pigment dust during renovation work) will also likely need to be addressed at some point in time
20
TiO2 Symposium
All presentations and videos from the symposium are
available at www.tio2symposium.com
A scientific paper published on ‘Relevance of the rat lung tumor
response to particle overload for human risk assessment—Update and
interpretation of new data since ILSI 2000’
21
ANNEX: SLIDES FROM TDMA
22
23
24
25
26
STANPAH UPDATE
27
REGISTRATION PROCESS ECHA 2018 ARE YOU PREPARED?
28
Manufacturers and importers putting on
the market substances over in quantities
between 1 and 100 tonnes will have to
register those substances by 31 May 2018.
Registration Process
29
Why is this important for you?
As Converter (or Masterbatcher / compounder) it is important to elaborate a list of the additives you are using and to communicate your suppliers if these substances are registered, or at least in process to be registered.
Why? Because if these substance are not registered by 2018 your supplier will not be able to put the substance on the market by law.
30
We, as the plastics converting industry EU level trade association will help converters to complete this process, providing them with instructions on what to communicate to suppliers to facilitate registration of their input substances.
EuPC has joined the REACH 2018 Communicators Network To facilitate this process we provide converters with the
tools that can be found in this communication pack: REACH tool EuPC sheet and instructions for its use – Inventory to
identify all the substances used. A Plastics Industry Specific Use Map for Communication to
relevant suppliers [to be circulated after this meeting]
EuPC role
31
SKIN SENSITIZERS AND SVHC
IDENTIFICATION
Verbal Update
32
ADCA
Verbal Update
33
ANHYDRIDES JOINT INDUSTRY TASKFORCE
34
Anhydrides Joint Industry Taskforce
Content
• Overview of the Anhydrides Joint Industry
Taskforce
• Overview of Regulatory Process
• What has been done
• Advocacy
Overview of AJIT
• The Anhydrides Joint Industry Taskforce
(AJIT) is a consortium for which Polymer
Comply Europe (PCE) is the Consortium
Manger
Overview of AJIT: Members
Overview of AJIT: Purpose
• To gather information on current exposure levels and risks associated with Anhydrides* and propose protective measures.
• To evaluate socio-economic impacts of an authorisation.
• To inform authorities of possible risk management options for the use of Anhydrides
* Anhydrides are HHPA and MHHPA , which have been identified as SVHC
Overview of AJIT: Overview of Use
• Anhydrides are used as
hardeners in epoxy
systems to produce
thermosets with superior
electrical insulation
properties
Overview of Regulatory Process
Authorisation Procedure
Respiratory Sensitization and REACH
• Regulators deem Respiratory Sensitization to
be an concern equivalent to that of
Carcinogens, Mutagens, and toxic to
Reproduction (CMR) substances.
• The substances HHPA and MHHPA were
put in the authorization process in 2012
Overview of the Regulatory Process
• Authorization is not a ban, but a change to a regime whereby industry needs to apply for permission to use a substance.
• In principle, not a bad idea
• In reality: – It creates massive uncertainty within the market
• Applying for authorization is no guarantee that authorization will be granted
– It places massive costs on industry • Dossier compilation and application fees can run into the millions
– Authorization is granted for a limited period of time • After authorization period is finished reapplication is required with
associated costs and uncertainty
Overview of the Regulatory Process
• (M)HHPA has been listed as an SVHC in 2012
• Every year ECHA compiles a ranking of SVHC Substances and scores these substances based on: 1) Intrinsic Properties, 2) Volume and 3) Use Pattern
Legislative Proposal is published in the Official Journal
Proposal includes latest application date and sunset data
REACH Committee Votes on Legislative Proposal
European Commission drafts Legislative Proposal
Prioritization for Authorization by ECHA
SVHC Listing
Background Document
Overview of the Regulatory Process
• ECHA picks from this ranking the top x substances and includes these in a draft recommendation for prioritization for authorization and opens a 60 day public consultation
Legislative Proposal is published in the Official Journal
Proposal includes latest application date and sunset data
REACH Committee Votes on Legislative Proposal
European Commission drafts Legislative Proposal
Prioritization for Authorization by ECHA
SVHC Listing
Overview of the Regulatory Process
• (M)HHPA were included in the draft 7th prioritization for authorization, but excluded from final 7th ECHA recommendation for prioritization for authorization, due to actions of AJIT
Legislative Proposal is published in the Official Journal
Proposal includes latest application date and sunset data
REACH Committee Votes on Legislative Proposal
European Commission drafts Legislative Proposal
Prioritization for Authorization by ECHA
SVHC Listing
Overview of the Regulatory Process
Inherent properties Volume Use Pattern
SVHC Inclusion Criteria based on REACH Article: Score Tonnage Score Use Score
57(a) or/and 57(b) or/and 57(c) or/and 57(f) 1 no volume 0 Industrial 5
57(f) (ED) 7 < 10 t/y 3 Professional 10
57(d) or 57(e) 13 10 - 100 t/y 6 Consumer 15
57(d) and (at least) one other SVHC property, or
57(e) and (at least) one other SVHC property 15 100 - 1000 t/y 9
1000 - 10000 t/y 12
> 10000 t/y 15
AJIT
Overview of the Regulatory Process
• (M)HHPA has not been included for the 8th round of prioritization, due to other substances with higher scores and ECHA selecting the top 7 (the number to include in the draft prioritization is up to ECHA)
• AJIT Activity has thus gained industry not 1, but 2 years of use
Legislative Proposal is published in the Official Journal
Proposal includes latest application date and sunset data
REACH Committee Votes on Legislative Proposal
European Commission drafts Legislative Proposal
Prioritization for Authorization by ECHA
SVHC Listing
Overview of the Regulatory Process
• However, it is very much possible and even likely that HHPA and MHHPA would be included in the 9th ECHA recommendation for prioritization for authorization.
Legislative Proposal is published in the Official Journal
Proposal includes latest application date and sunset data
REACH Committee Votes on Legislative Proposal
European Commission drafts Legislative Proposal
Prioritization for Authorization by ECHA
SVHC Listing
Overview of the Regulatory Process
• European Commission is expected to draft a Legislative Proposal
• The Legislative proposal will include: – A latest application date,
before which all companies applying for authorization need to submit their dossier
– A sunset date after which only applicants for authorization may continue to use the substance
Legislative Proposal is published in the Official Journal
Proposal includes latest application date and sunset data
REACH Committee Votes on Legislative Proposal
European Commission drafts Legislative Proposal
Prioritization for Authorization by ECHA
SVHC Listing
Overview of the Regulatory Process
• There is no timeframe in which the Commission has to submit a legislative proposal
– Substances from the 3rd and 4th round of prioritization for authorization have not yet been put forward for authorization.
Legislative Proposal is published in the Official Journal
Proposal includes latest application date and sunset data
REACH Committee Votes on Legislative Proposal
European Commission drafts Legislative Proposal
Prioritization for Authorization by ECHA
SVHC Listing
Overview of the Regulatory Process
• The European
Commission’s REACH-
Committee* needs to vote
on the legislative proposal
• The REACH Committee
consists of
representatives of the 28
Member states
Legislative Proposal is published in the Official Journal
Proposal includes latest application date and sunset data
REACH Committee Votes on Legislative Proposal
European Commission drafts Legislative Proposal
Prioritization for Authorization by ECHA
SVHC Listing
*Committee set up under Regulation (EU) No 182/2011
Overview of the Regulatory Process
• The REACH Committee votes examination procedure, meaning: – Positive votes
representing 65% of the EU population needs to support the proposal*. i.e. we need the combined support of member states representing 35% of the EU population to block the authorization procedure
Legislative Proposal is published in the Official Journal
Proposal includes latest application date and sunset data
REACH Committee Votes on Legislative Proposal
European Commission drafts Legislative Proposal
Prioritization for Authorization by ECHA
SVHC Listing
*Examination procedure referred to in Regulation 182/2011
Overview of the Regulatory Process
• If the legislative proposal is passed the proposal will be published in the official journal and companies will have to apply for authorization in order to keep using the substances
• The latest application date is likely to be 18 months after publication in the official journal
• The sunset date is likely to be 18 months after the latest application date
• Sunset date is expected to be in 2020 20212022
Legislative Proposal is published in the Official Journal
Proposal includes latest application date and sunset data
REACH Committee Votes on Legislative Proposal
European Commission drafts Legislative Proposal
Prioritization for Authorization by ECHA
SVHC Listing
What has been done
What has been done: Public
Consultation Report
• Anhydrides Joint Industry Taskforce (AJIT) was set up in December 2015
• Immediately collected of all available information Public Consultation Report (available on anhydrides.eu)
– Industry was lacking:
• Workplace exposure measurements (partially due to lack of validated measurement methodology)
• Medical data to counter regulators concern
Harmonized Measurement Methodology
• No validated measurement methodology
existed
• Technical Committee harmonized existing
methods
• Methodology available to AJIT Members and
all members have or will be performing
exposure measurements
Medical Diagnostic Guideline
• Occupational Asthma related to Anhydrides is likely to be very rare.
– Diagnosis of diseases is a matter of pattern recognition. If a medical professional has not seen a disease for years it is more difficult to recognise.
• Occupation Asthma related to Anhydrides is very similar to hay fever/general asthma/other respiratory disease.
– Misdiagnosis is likely to occur.
• Occupational Asthma related to Anhydrides is nearly impossible to diagnose with certainty without immunological testing.
– It is doubtful that all your medical professionals have heard of or have access to sIgE determinations required for establishing causality
Medical Diagnostic Guideline
• Medical Diagnostic Guideline (MDG)
– Provides a highly sensitive method for the detection
of Occupational Asthma related to anhydrides
– Developed together with Professor Paul Cullinan of
the National Heart & Lung Institute at Imperial
College, London
• Available to AJIT Members and will be shared
on request to interested parties
Exposure and Medical Inventory Report
• Contains a detailed overview of exposure measurements in three sectors: – Producers/formulators
– Producers of SwitchGear
– Producers of Motors/Generators
Voluntary Commitment
• A Voluntary Commitment
was developed and
adopted by AJIT Members
and is currently being
presented as an alternative
to authorization
Voluntary Commitment
Signatories agree to:
• Implement the AJIT Medical Diagnostic Guidance
• Implement an exposure reduction plan – Measure exposure with AJIT Methodology
– Formulate exposure minimization plan
– Execute exposure minimization plan
– Measure effectiveness of minimization plan
– Report to AJIT on the results
• Implement a, to be developed, AJIT worker training program
• Assist in the improvement of the measurement methodology
Voluntary Commitment
• Once a practice becomes standard among AJIT Members it is communicated throughout the supply chain through Exposure Scenario Annexes to the Safety Data Sheet
Manufacturers/Importers
Formulators
Downstream End-Users
eSDS
ES
eSDS
ES
Voluntary Commitment
• REACH Articles 37 – 39 specify that downstream users are obliged to: implement the recommendation included in an Exposure Scenario within 12 months upon receipt of the Safety Data Sheet
Manufacturers/Importers
Formulators
Downstream End-Users
eSDS
ES
eSDS
ES
WIDER DEBATE
65
Workshop Equivalent Concern
EuPC and AJIT are in contact with Cefic
to look into a possibility to hold a joint
workshop on the place of respiratory
sensitizers in the SVHC roadmap
66
PHTHALATES UPDATE
Presentation by ECPI
67
CADMIUM RESTRICTION
Presentation by Polycomply Hoechst
68
FAST-TRACK RESTRICTION ON CMR IN
TEXTILE
69
Recap
European Commission is developing a REACH restriction on CMRs in textiles, which will follow the fast track/simplified procedure (Art 68(2))
The text of the proposed restriction will include: Identification of substances
Specific values based on the content
Specification of the kind of articles that are covered
Specific derogations
Transitional period for the application of the restriction
70
Latest Developments
On 7 February the Commission presented the following Timeline: Present a draft to REACH Committee by July
Vote in the REACH Committee in September
Reflect on experience after the summer
It also stated that I was willing to consider derogations and that stakeholders are invited to send their supporting documentation by 28 April
71 More Information: http://ow.ly/jXmG30abYLX
Articles in Scope
The Commission intends to cover all clothing articles and footwear (due to the potential direct contact with the skin) as well as other textile articles where the contact with the skin is comparable to clothing (bed linen, pillow cases, towels…)
The Commission will prepare a non-exhaustive list of article (including potential borderline cases) covered in the restriction and include it in a Q&A, that could be updated when needed.
72
Substances in Scope
The Commission is now considering substances that fall in the following groups of substances: Formaldehyde
Heavy Metals (Cd, Cr, As, Pb)
Chlorinated aromatic hydrocarbons
Phthalates
Aprotic Solvents
Benzene and PAHs
Azo-dyes and arylamines
Quinoline
73 Full list available online: http://ec.europa.eu/DocsRoom/documents/21466
Full list of substances in Scope
Formaldehyde
Cadmium sulphate, Cadmium/cadmium (pyrophoric), Cadmium chloride, Cadmium oxide/cadmium oxide (non-pyrophoric), Cadmium sulphide
Ammonium dichromate, Calcium chromate, Chromium (VI) trioxide, Chromyl dichloride, Dichromium tris(chromate); chromium III chromate; chromic chromate, Sodium chromate, Sodium dichromate, Strontium chromate, Potassium chromate, Potassium dichromate, Chromic acid, lead(2+) salt (1:1)
Lead hydrogen arsenate, lead 2,4,6-trinitro-m-phenylene dioxide; lead 2,4,6-trinitroresorcinoxide; lead styphnate, lead di(acetate), lead diazide; lead azide, Chromic acid, lead(2+) salt (1:1)
74
Full list of substances in Scope
a,a,a,4-tetrachlorotoluene, a,a,a-trichlorotoluene, a-chlorotoluene
1,2-Benzenedicarboxylic acid, di-C6-8-branched alkyl esters, Bis(2-methoxyethyl) phthalate, diisopentylphthalate, Di-n-hexyl phthalate (DnHP), Dipentyl phthalate (DPP)
N-methyl-2-pyrrolidone; 1-methyl-2-pyrrolidone (NMP), N,N-dimethylacetamide (DMAC), Dimethylformamide (DMF)
Benzene and Polyaromatic Hydrocarbons
75
Full list of substances in Scope
Basic violet 3, Disperse Blue 1, Basic Red 9, Disperse orange 149, Direct Red 28, Direct Blue 6, Direct Black 38, Direct Brown 95, 4-chloro-o-toluidinium chloride, 2-Naphthylammoniumacetate, 4-methoxy-m-phenylene diammonium sulphate, 2,4,5-trimethylaniline hydrochloride, N,N,N',N'-tetramethyl-4,4'-methylenedianiline (Michler's base), 4,4'-bis(dimethylamino)benzophenone (Michler's ketone), azobenzene
Quinoline
dibutyltin dichloride (DBTC)
76
EuPC is following up on the issue as might affect the plastics industry directly.
More importantly, the restriction sets precedent for the use of the fast-track restriction procedure which can be used in the future for plastic articles.
EuPC maintains contact with EURATEX on this issue
EuPC acitvities
77
LEAD RESTRICTION AND AUTHORISATION
78
Proposed restriction
Echa published a restriction proposal for Pb on 21 December 2016
See : https://echa.europa.eu/registry-of-submitted-restriction-proposal-intentions/-/substance-rev/15539/term
Timeframe : 2 years after the entry into force of the restriction to allow
exhaustion of stocks: ie at the earliest June 2020.
derogation for specific uses of recyclate (see below): 15 years after entry into force ie at the earliest June 2033
derogation for PVC silica separators in lead batteries : 10 years.
Proposed restriction : scope
Articles or part thereof shall not be placed on the market if they contain more than 0.1% of lead
Derogation for second hand market (e.g. second hand windows)
Derogation for uses of PVC recyclate:
The following articles containing recycled PVC may contain up to 1% of Pb metal profiles and rigid sheets for building applications;
doors, windows, shutters, walls, blinds, fences, and roof gutters;
cable ducts;
fittings for tubes, furniture etc.;
pipes for non-drinking water, if the recycled PVC is used in a multilayer pipe and is entirely enclosed with a layer of virgin PVC
Proposed restriction : Echa risk
assessment approach
Increased PVC imports in the period
2010-2015 (+140%)of which 70% from
Asian countries were Pb still used
Echa problem definition/risk to
addres
Exposure routes
Echa annex XV report Pb, p. 23
Derogation recycling scope:
justification by ECHA
Minor contribution and low risk from
selected application
Coherence with Cd derogation
Enforceability
ECHA SECTORIAL STRATEGY PLASTIC
ADDITIVES
85
Background
On 25 November ECHA and Cefic co-hosted a meeting to present the ECHA Sectorial Strategy on Plastics Additives which EuPC attended
ECHA clarified that they are looking for cooperation from industry to improve priority setting in their substance evaluation process
At the moment both ECHA and Industry feel that the current approach results in more or less random selection of substances for further investigation
ECHA therefore seeks the help of industry to determine criteria to prioritize and deprioritize substances for evaluation
86
Potential Impact for Plastics
Converters
As a general principle it would be good
to know/define the criteria that would
result in further investigation of plastic
additives as this will allow industry to
enjoy a level of regulatory predictability
87
ECHA Sector Approach
The ECHA Sector Approach rests on three
pillars
1. The development of an inventory of plastic
additives
2. The development of a Plastics Industry
specific Use Map Package
3. Defining criteria and approaches to
determine high and low exposure potential
88
The development of an inventory
of plastic additives
ECHA has taken the first step to develop an initial inventory of plastic additives by using key words (e.g. antioxidant, flame retardant, plastic additive) and searching the registration database
This inventory was made available to industry and a request was made to refine/complement this database
89
The development of an inventory
of plastic additives First impression
Many false positives (e.g. bromine, lead mono-oxide, urea)
900 Substances, implies a lot of work needs to be done
Further processing by Industry As a first step this inventory will be screened by Cefic, which will remove false
positives and perhaps some high volume substances that were missed by ECHA by end first week of May
In a second step Masterbatchers, Compounders, and Converters will be asked to check orphan substancesby end June
EuPC hereby requests your help to identify capable experts on plastics additives uses
Intermediate step for EuPC (to anticipate June deadline) : identify substances commonly used as plastics additives not in ECHA list (e.g. products not well identified products not with a EU registrant…) (April until early May: as a first step-
90
The development of a Plastics Industry
specific Use Map Package
A Use Map Package includes: A Use Map, providing a general description of the
uses in the plastics industry (comparable to Generic Exposure Scenarios)
Specfic Worker Exposure Determinants (SWED), describing the operating conditions and risk management measures in a sector
Specific Environmental Release Categories (SpERC), describing the environmental emissions to be expected in a sector
91
The development of a Plastics Industry
specific Use Map Package
A Use Map Package includes:
A Use Map, EuPC/EuMBC wil convert the PEST GES
into the new Use Map template
Specfic Worker Exposure Determinants (SWED),
will be provided in a guidance to assessors
Specific Environmental Release Categories
(SpERC), will be created by converting the OECD
Emission Scenario Document for Plastics Additives
92
The development of a Plastics Industry
specific Use Map Package
The benefit of providing these use maps will be that it will allow registrants to update their registration dossier and will result in: More clear communication to downstream
users in Exposure Scenarios
More concise registration dossiers for plastics additives will in any screening approach result in a more favorable treatment
93
Defining criteria and approaches to
determine high and low exposure potential
Cefic will set up an ad-hoc group to define these criteria, EuPC and Plastics Europe will be invited to contribute
Need experts with the following profiles
Wide knowledge of applications and uses
Knowledge of exposure to plastics (migration, abrasion…)
Toxicologists
First meeting to set strategy and objectives of this work in May
94
BENZOTRIAZOLES UV STABILIZERS
95
Status quo
Benzotriazoles UV stabilizers are under review by German REACH Competent Authority as these are suspected of being either Persistent, Bioaccumulative, and Toxic (PBT) or very Persistent and very Bioaccumulative (vPvB) substances.
If identified as a PBT or vPvB substance, these substances will identified as Substance of Very High Concern (SVHC) and proceed down into the authorization process
The German CA will progress once bioaccumulation studies are available for all Benzotriazoles
96
Benzotriazoles at stake
Name Cas No. Registration Study
Planned
SVHC Reason for
Inclusion
UV-P 2440-22-4 Yes No No
UV 171/517 125304-04-3 No NA No
UV 234 70321-86-7 Yes Yes No
UV 320 3846-71-7 No NA 17/12/2014 PBT and vPvB
UV 326 3896-11-5 Yes No No
UV 327 3864-99-1 No NA 17/12/2015 vPvB
UV 328 25973-55-1 Yes No 17/12/2014 PBT and vPvB
UV 329 3147-75-9 Yes Yes No
UV 350 36437-37-3 No NA 17/12/2015 vPvB
UV 928 73936-91-1 Yes NA No 97
Status Quo
It is expected that not all Benzotriazole
will end up being classified as PBT or vPVB
but some will.
98
Potential alternatives
Other Benzotriazoles which are currently not under evaluation; or which are under evaluation, but for the BCF is below the threshold for SVHC listing.
Benzophenones are potential alternative UV-absorbers, although these are investigated for endocrine disrupting properties.
Hindered Amine Light Stabilisers (HALS) are not UV-absorbers but are able to inhibit degradation by being proton donators, which clear radicals formed by UV radiation.
Other potential UV-Stabilisers are: Triazines
Oxanilides
Cyanoacrylates
Nano TiO2
99
Actions/questions
Are some of the above mentioned Benzotriazoles critical (i.e. not substitutable)? Because of specific technical properties to be
achieved
Because of important additional cost
Further actions to be envisaged if this is the case
So far, Masterbatchers and Compounders indicated that alternatives are able to provide required functionality.
100
BIOELUTION
101
Bioelution is the migration of substances from (matrix) mixtures to biological fluids
For metals there is experience and work being performed to demonstrate that bioelution does not occur through specific testing using biological simulants (interstitial, lysosomal, gastric, and perspiration)
If bioelution does not occur then a substance would also not be bioavailable
Bioelution: Concept
102
Where, as a result of the evaluation carried out (…) the following properties or effects are identified, manufacturers, importers and downstream users shall take them into account for the purposes of classification:
a) (…)
b) conclusive scientific experimental data show that the substance or mixture is not biologically available and those data have been ascertained to be adequate and reliable;
c) (…)
Bioelution: CLP Art 12
103
During CARACAL 21 the declassification of mixtures based on bioelution data was discussed The EC legal service provided an interpretation of Art. 12
of the CLP-Legislation
Several member states have commented on this interpretation
There is a possibility that if the debate goes in the right direction declassification of mixtures containing CMR substances if they do not elute during bioelution studies. Major potential implications for Plastics Converting Industry
Bioelution: High Level Discussion
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The EC Legal Service provides the following interpretation: Article 12(b) applies to environmental and health
hazards
Bioavailability data (obtained with a future bioelution test) can be used for classification as well as non-classification of mixtures containing CMR substances
Biologic availability data can be used even for mixtures containing CMRs with even if these have a specific concentration limit
“not biologically available” should be taken to mean “not biologically available below a certain threshold”
Bioelution: EC Legal Service
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Country
12(b) Applicable to “not biologically available below a certain threshold” Health Hazards CMRs
CMRs with Specific Concentration Limit
(SCL)
Netherlands Agrees EC Def. Agrees EC Def. Agrees EC Def. Agrees EC Def.
Germany Yes (to the letter, not spirit)
No (Art 6(3)) No, would undermine SCL principle
Bioelution ≠ bioavailable
Denmark No (Art 6(3)) No (Art 6(3)) No (Art 6(3)) Does not accept EC Def.
Spain Agrees EC Def. Reasonable Agrees EC Def. Agrees EC Def.
Finland Yes Maybe, for alloys
and Polymers Need more
research Technical problem
with threshold and needs more research.
Greece Agrees EC Def. Agrees EC Def. Agrees EC Def. Agrees EC Def.
Bioelution: MS Response
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If the wider debate moves to favor of EC interpretation:
The recycling of plastics containing hazardous
substances could lead to non-classified product
Masterbatches and Compounds containing CMR
substances would no longer need to be classified
as such, if bioelution is shown not to occur
Solution to the TiO2 issue and potentially other
particle based additives as well
Bioelution: Potential Implication
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The Bioelution Concept is in its infancy
To work on clarification of the bioelution concept ECHA has set up a working group consisting of: Representatives of: European Commission, Hungary, Begium, Germany,
Norway, Austria, Denmark, Bulgaria, United Kingdom, Sweden, and the Netherlands (RIVM)
Industry Organisations: ETRMA, CEPE/DUCC, Eurofer, Eurometaux, ECVAM, and EuPC
Meetings: 4 November Introductory Teleconference
25 January Physical Meeting in Helsinki
EuPC has prepared briefings for this working group on: I. Definition of Bioelution
II. Practical Examples of why Bioelution is a Worst Case Estimation of Biological Availability
III. Currently Existing Knowledge on the Migration of Additives from Plastics
Bioelution: Action - ECHA working
group
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CHEMICAL PRODUCT WASTE INTERFACE
ROADMAP
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EU CIRCULAR ECONOMY ROADMAPS
AND DANGEROUS SUBSTANCES
110
EC roadmap on the strategy on plastics in a
Circular Economy of 26/01/2017
Does not address hazardous legacy additives
Focuses on marine litter and leakage in the
environment
Mentions that « environmental externalities » not
sufficiently accounted for (i.e. (EPR).
However refers to UN sustainable development
goals which include that « toxic chemicals should
handled in an environmental sound manner »
Still technical barriers for « feedstock recycling »
EC roadmap on the « analysis of the interface between
chemicals, products and waste legislation of 27/01/2017
4 main stumblings blocks according to EC:
#1: Insufficient information about substances of concern in products and waste
#2: Presence of substances of concern in recycled materials and in articles made thereof
#3: Uncertainties about how materials can cease to be waste
#4: Difficulties in applying EU waste classification methodologies and impacts on the recyclability of materials
EC roadmap on the « analysis of the
interface between chemicals, products and
waste legislation : highlights
#2: Presence of substances of concern in recycled materials and in articles made thereof : “Currently there is no general framework to deal with the presence of substances of concern in recycled materials and in articles made thereof and, in particular, no agreed methodology to determine the overall costs and benefits for society of the use of recycled materials containing such substances compared to disposal of, or energy recovery from, the waste and the impacts of production of virgin materials in case recycling is prevented.”
#4: Difficulties in applying EU waste classification methodologies and impacts on the recyclability of materials :”[ ]Lack of consistency in terms of application and enforcement of waste classification methodologies leads to uncertainty about the legality of waste management practices of certain important waste streams containing substances of concern in a complex material such as minerals, plastics or glass”
ANY OTHER BUSINESS
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