rmc meeting presentation · telcon on a quartely basis implementing advocacy at national level 11 ....

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


Public Consultation ran from 31May 2016 till 15 July

2016

EuPC and MedPharmPlast

Europe Submitted a

position paper to this

consultation





7


ECHA Risk Assessment Committee has 18 months

to develop opinion.

TiO2 should therefore be

done by Nov. 2017





8


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





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

http://www.tio2symposium.com/

http://www.sciencedirect.com/science/article/pii/S0300483X1630292X







ANNEX: SLIDES FROM TDMA

22

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


• (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

https://echa.europa.eu/documents/10162/13640/gen_approach_svhc_prior_in_recommendations_en.pdf/e18a6592-11a2-4092-bf95-97e77b2f9cc8


• 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






SVHC Listing


• (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






SVHC Listing


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


• (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






SVHC Listing


• 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.






SVHC Listing


• 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






SVHC Listing


• 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.






SVHC Listing


• The European

Commission’s REACH-

Committee* needs to vote

on the legislative proposal

• The REACH Committee

consists of

representatives of the 28

Member states






SVHC Listing

*Committee set up under Regulation (EU) No 182/2011


• 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






SVHC Listing

*Examination procedure referred to in Regulation 182/2011


• 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






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

http://anhydrides.eu/

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


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


• 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


• 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

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

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


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


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.

https://echa.europa.eu/registry-of-submitted-restriction-proposal-intentions/-/substance-rev/15539/term















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


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



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 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

https://echa.europa.eu/support/authorisation/substances-of-very-high-concern-identification

https://echa.europa.eu/support/authorisation/substances-of-very-high-concern-identification

https://echa.europa.eu/regulations/reach/authorisation

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

https://echa.europa.eu/registration-dossier/-/registered-dossier/13300/1



https://echa.europa.eu/substance-information/-/substanceinfo/100.043.062


https://echa.europa.eu/substance-information/-/substanceinfo/100.102.117

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

104

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

105

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

106

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

107

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

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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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www.plasticsconverters.eu

[email protected]

https://twitter.com/EuPCplastics

https://www.linkedin.com/company/european-plastics-converters?trk=biz-companies-cym

rmc meeting presentation · telcon on a quartely basis implementing advocacy at national level 11 ....

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