echa’s perspective on substances in products - … · echa’s perspective on substances in...

ECHA’s perspective on substances in products

SEMICON West 2016Sustainable Manufacturing Forum

Rémi LEFEVREScientific officerClassification and prioritisation unitRisk Management DirectorateECHA

12 July 2016

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European Chemicals Agency - ECHA

• An EU “decentralised agency”; decentralisedagencies have been set up by the EU to perform technical and scientific tasks that help the EU institutions implement policies and take decisions

• Based in Helsinki, Finland

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ECHA key facts• Started on 1 June 2007• 600 staff from 28 countries

• Main legislations:• 2007: REACH• 2009: Classification and

Labelling• 2013: Biocides • 2014: Prior Informed Consent

• Nano-observatory, POP (support to Commission), Poison Centres

Implementing European chemicals legislation

• REACH – Registration, Evaluation, Authorisation and Restriction of Chemicals (2007)

• CLP – Classification, Labelling and Packaging (2009)

• BPR – Biocidal Products Regulation (2013)• PIC – Prior Informed Consent (2014)

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Main activities

• Manage REACH, CLP, Biocides and PIC• Disseminate information on chemicals• Develop scientific IT tools• Provide regulatory assistance to industry

(helpdesk and guidance)• Support enforcement• Advise EU institutions and Member States on

chemical safety• Assist EU’s international activities (UNEP and

OECD; accession countries)

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My objectives for today

• To give you an overview of what is going on regarding substances in articles (SiA) under REACH

• To discuss your questions/concerns, the challenges you are facing and any proposals on how to implement REACH provisions in a practical and efficient manner

• Our ultimate goal: ensuring safe use of articles

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Contents

• Brief recap about REACH

• The challenges of getting and sharing the relevant information on substances in articles

• Restrictions on substances in articles under REACH

• What’s next? Being aware of potential future regulatory measures under REACH & CLP

REACH in (very!) brief

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Objective of REACH• REACH recital 1: “[…] ensure a high level of

protection of human health and the environment as well as the free movement of substances, in mixtures and in articles, while enhancing competitiveness and innovation. […]”

• To ensure a safe(r) use of chemicals

• REACH addresses both environment and human health (workers and consumers)

• REACH is without prejudice of other specific EU legislation, e.g. workers’ protection, waste (RoHS); aiming at supporting them

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Terminology (art. 3 REACH)• Under REACH:

• substance (art. 3.1)• mixture (previously “preparation”): “mixture or solution of

two or more substances”• article: “object which during production is given a special

shape, surface or design which determines its function to a greater degree than does its chemical composition”

• A substance can be mono-constituent or multi-constituent; additives and impurities are constituents

• Usually, “products” cover “articles” and “mixtures”, as well as combinations of those

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Main principles of REACH• Only EU-based legal entities have obligations

under REACH… but to comply, they need input from their non-EU suppliers!

• “Reversal of the burden of the proof”: Industry's responsibility to ensure proper risk management of chemicals; regulatory action (i.e. restrictions on uses of certain substances) is taken by public authorities only were harmonised action is warranted

• Main source of information for public authorities: Registration dossiers

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Three main pillars of REACH

• Registration: getting information generated by Industry (Industry)

• Dossier/Substance Evaluation: filling data gaps/clarifying properties (ECHA / Member States)

• Regulatory Risk Management (Authorisation / Restriction) (Commission / Member States)• Starting point: Registration data

Substances in articles (SiA):

the challenges of getting and

sharing relevant information

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Why ensuring safe use of chemicals in articles?

• To comply with (REACH) legal obligations…• an objective or a tool?

• Other reasons?

Substance in Articles: a growing interest from general public

• Consumers are more aware of the “chemicals”

topic; they ask for safe, or even “toxic-free”

products

• Non-Governmental Organisations (environment

/ consumers) active on this issue, including via

eco-labelling schemes16

Substances in Articles: a higher political attention• International:

• UN: 2002 WSSD goal to ensure “the minimisation of significant adverse effects” of chemicals on human health and the environment by 2020, SAICM / Chemicals In Products programme

• OECD (exposure assessment, use descriptions, substitution)

• At EU level: 7th Environment Action Programme to 2020 - “Living well, within the limits of our planet”:• objective of a non-toxic environment (strategy to be

developed by 2018),• concepts of circular economy & “non-toxic material

cycles”17

Substances in Articles: some companies take a pro-active attitude

• E.g.:• Voluntary initiatives (e.g. the “Roadmap to Zero Discharge

of Hazardous Chemicals” initiative – ZDHC;www.roadmaptozero.com; H&M, Levi’s, Nike, Puma, Adidas, Gap, Marks & Spencer, C&A, Esprit, etc.)

• Individual commitments – e.g. IKEA

• Why?• Corporate liability to ensure safe use of articles during

their service-life and waste stage• Sustainability

• Necessary for product stewardship and to avoid reputational risks and liabilities

• Support search for, and transfer to safer alternatives

• Marketing advantage (i.e. business opportunities)

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How to ensure safe use of chemicals in articles? a) Information on which substances are present in an

article, where, and at which level• Impacts the exposure potential during the service life, and

hence the necessary risk management measures for the safe use of the article and its disposal

b) Effective and focused communication within the supply chains• Across the EU border and within the EU• Throughout the supply chain from manufacturer/importer of

chemicals, materials or articles until the final customer and waste management

c) Targeted (regulatory) action from authorities, where needed

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How are substances in articles (SiA) addressed under REACH? (1/6)

• For registered substances (on their own or as mixtures), all life-cycle stages should be covered in registration dossiers, including incorporation and uses in articles

• Industry has to compile the necessary information about properties and uses of substances, and then develop and implement risk management measures, including for article service-life stage

• for many/most articles uses, the information should already be available from Registration dossiers

• so far, very limited/low quality data on articles

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How are SiA addressed under REACH? (2/6)

• In addition, a limited number and targeted SiA-specific obligations:• Notifications (to ECHA) and communication obligations• Restrictions mechanisms

• 3 pillars for addressing SiA under REACH:• Pillar #1: information generation• Pillar #2: communication within supply chains• Pillar #3: where needed, regulatory measures

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The legal provisions - Objectives

• Art. 7.2 (notification): to complement information on substance in articles on the EU market

• Art. 33 (communication): to allow all actors in the supply chains (incl. consumers) to implement the necessary risk management measures, and make an informed supply choice

• Art. 69 (restriction): to allow public authorities to adopt restrictions on the placing on the market/use of substances, incl. in articles

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The legal provisions

• Art. 7.2: requires notification to ECHA if an SVHC is present in a quantity exceeding 1 tonne per annum in articles produced or imported and it is present in those articles at above 0.1% (unless exposure can be excluded or the substance has already been notified for that use [Articles 7(3)/ 7(6)]))

• Art. 33: requires that for SVHC substances present in articles at above 0.1 % the supplier must provide the recipient of the article and (on request) the consumer with sufficient information, available to the supplier, to allow safe use of the article […]

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SVHC?

• SVHC stands for “Substances of Very High Concern”

• Substances with hazard properties of highest concern for human health or the environment:• Carcinogens, Mutagens, toxic to Reproduction (CMRs), or• PBT, or• vPvB, or• of “equivalent level of concern” (e.g. Endocrine Disruptors,

(respiratory) sensitisers, STOT RE)

AND

• listed in REACH “Candidate List” (for authorisation) –updated twice a year!

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Main (practical) challenges• To know about the presence of a SVHC substance

in an article, in particular:• when involving very complex supply chains• when incorporated in a bigger, very complex article

• To communicate the presence of the SVHC is an appropriate and efficient way

Questions:• What does the recipient need as information to ensure safe

use? How knowledgeable is he/she about chemicals?• How (format/tools) to share information in supply chains?

What are the (financial/organisational) capacities of actors?• How to make it fit-for-purpose / proportionate?

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Challenge #1: How to ensure efficient tracking and reporting mechanisms?

• How to get the necessary information?• Complex and/or global supply chains• Suppliers with limited awareness / capacities• What information is needed?

• Enforcement: what will be requested by National Enforcement Authorities? role of testing?

• Communication systems to be established?

Questions: is there room for harmonisation in formats/reporting systems? Is ECHA needed?

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Life-cycle of chemicals

Subst/mixt. manufacturers

Material/article

producers

M / I (Reg)Formulators

(DU)

Material/article producers

(DU)

Importers/final articleproducers

Recyclers Customer Waste managt

Non EU EU

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Information flow in (global) supply chains

EU

Article importer

Article producer

Material producer

Substance manufacturer

Consumer

SVHC?Restricted substance?

SVHC?

Don’t be passive...

Be proactive!

? ?

Industrial and professional users

Safe use instructions

Enforcement Authorities

Restrictions

The rest of the world

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Challenge #2: Determining the concentration of an SVHC in an article / The “0.1% issue”

Remark: ECHA’s advice = in case of doubt, probably better to notify

• Question: in the case of objects which are “complex articles” (or “complex objects” and also conformed to the definition of an article under REACH), does the 0.1% limit apply to the “complex article” as a whole or to each of the component articles

• Long discussion for several years, with 6 dissenting Member States; went to European Court of Justice

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Challenge #2: Determining the concentration of an SVHC in an article / The “0.1% issue”Question to the Court

“Where an article within the meaning of the REACH Regulation is composed of several elements which themselves meet the definition of article in the regulation, are the obligations resulting from Article 7(2) and Article 33 of the regulation to apply only with regard to the assembled article or with regard to each of the elements which meet the definition of article?”

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Challenge #2: Determining the concentration of an SVHC in an article / The “0.1% issue”Ruling of the Court (i)

1. Article 7(2) of [REACH], must be interpreted as meaning that, for the purposes of application of that provision, it is for the producer to determine whether a substance of very high concern identified in accordance with Article 59(1) of that regulation, as amended, is present in a concentration above 0.1% weight by weight of any article it produces and, for the importer of a product made up of more than one article, to determine for each article whether such a substance is present in a concentration above 0.1% weight by weight of that article.

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Challenge #2: Determining the concentration of an SVHC in an article / The “0.1% issue”Ruling of the Court (ii)

2. Article 33 of [REACH], must be interpreted as meaning that, for the purposes of application of that provision, it is for the supplier of a product one or more constituent articles of which contain(s) a substance of very high concernidentified in accordance with Article 59(1) of that regulation in a concentration above 0.1% weight by weight of that article, to inform the recipient and, on request, the consumer, of the presence of that substance by providing them, as a minimum, with the name of the substance in question.”

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Challenge #2: Determining the concentration of an SVHC in an article / The “0.1% issue”

Consequences of the ruling• Basically the ruling clarified that in the case of

what in the ruling is termed “complex products” in the judgement (“complex articles” in Version 2 from 2011 of the ECHA guidance) the focus in determining whether the 0.1 % threshold was exceeded needs to be on each component article of a complex product;

• This meant that the ECHA guidance available at the time (which considered the 0.1% limit to apply to the complex article as a whole) was no longer aligned with the judgement, and needed to be updated as soon as practicable.

Manufactured Items

A Kettle Lid base

A’ Kettle lid with E welded on top

B Kettle spout

C Kettle Body

D Kettle Handle

E Cadmium plated steel screw stud

F Complete Tea Kettle

B

C

5

D

2

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4

Applying ECJ ruling: How Many Articles in this Tea Kettle?

AE A’

weld

Material transition region

Direct Components

1 Cadmium – a substance

2 Steel alloy sheet stock – a mixture

3 Thermoplastic sheet stock – a substance with UV 328 additive

4 Cadmium plated steel alloy screws

5 Lid knob made from same material as 3

6 Glue – a mixture

7 Welding Rod – a mixture

F

weld

6

7

8

32

14

5

6

78

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ECHA’s ongoing activities on SiA (1/5)

Based on legal text, rather limited activities

• Art. 7(2), mainly:• Collecting and disseminating notification (+

registration) data• Some communication/awareness-raising actions,

including outside the EU• Guidance (see next slides)

• Art. 33: communication + indirect support via CSA Programme

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• Update of the Guidance on Substances in Articles

• Main change: aligning with the September 2015European Court of Justice judgement (“once an article,always an article”); this will include new examples, inparticular to cover “complex products”

• Timeline:• July 2016: draft updated guidance sent to Partners Expert Group

(PEG)• October 2016: PEG meeting• Q1 2017: publication of updated guidance

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• Update of the Guidance on Substances in Articles (cntd)

• Pre-consultation of PEG members on draftnew/updated examples in May 2016

• Main suggestions/claims:• changes in structure, simplifying content, correct edits and

grammar, for better clarity• recurrent issues on interpretation of whether a product is an

article or a mixture• in relation with ECJ ruling:

– more examples, in particular to illustrate very complexarticles and/or complex supply chains

– more “proportionate and practical” guidance• not going further than what REACH/ECJ strictly say

• Continuous improvement of tools (for use description) and guidance (general guidance on duties, examples of exposure assessments for substances in articles)

• Support to the development of a pilot enforcement project, which operational phase is currently foreseen for second half of 2017

• Gathering and dissemination of information (ECHA website)

• Communication and awareness raising activities, towards specific sectors / retailers’ associations

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• Exploring how to better support:• dutyholders: the “MIP” project, tools to improve

communication within supply chains,…• consumers: tools for an easier access to

information on substances in articles (e.g. phone apps)

• public authorities:−defining and finding substances to be

addressed via regulatory action ( screening, based on good quality data from Industry!)

−providing information sources, for development of e.g. restriction proposals

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Regulating the use of substances in articles: REACH Restrictions

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Risk management: restrictions• When unacceptable risks to humans or the

environment have been identified

• Placing on the market of (imported) articles can be subject to restriction• Special procedures for consumers articles containing CMRs

(68(2))• Systematic assessment for articles containing Annex XIV

substances (69(2))

• Procedure:• Member State competent authorities can submit dossiers

proposing restrictions (or ECHA on behalf Commission)• European Commission decision based on opinions of ECHA

scientific committees (RAC & SEAC)

• Annex XVII of REACH lists all restrictions

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PFOA Restriction proposal – Timeline

• Developed by DE and NO; officially submitted in October 2014

• Opinions of ECHA scientific committees adopted in September and December 2015

• Now with European Commission, for final adoption

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Derogations and review• Exemptions proposed for:

• semiconductor photolithography processes and etching processes of compound semiconductors – no end date

• the placing on the market of semiconductor manufacturing equipment – 5 years from EiF

• the placing on the market of secondhand articles for which an end-use in the European Union before the restriction becomes effective can be demonstrated – no end date

• Review of the whole restriction, including derogations:• SEAC recommends a 5-year review period after EiF

• for Commission to decide whether, when and how to initiate the review

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Implementation and enforcement

• Main actor = Member States’ National Enforcement Authorities (NEAs)• the ECHA Forum can have a role in discussing the way(s)

to enforce the restriction

• How to prove compliance (to 25 ppb limit):• for NEAs to decide what they will accept as proof of

compliance

Being aware and getting

involved in possible future

regulatory measures

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Advice (1/2)

To be aware early enough about potential future obligations/restrictions under REACH, regularly check on ECHA’s website:

• At very early stage: “Public Activities Coordination Tool – PACT”

• “Registry of Intentions (RoI)”

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Advice (2/2)

• Do not forget that Annex XIV substances (Authorisation) will be reviewed under 69(2) procedure ca. 1 to 2 years after the “Sunset Date”, for the need to restrict their use in articles

• Share your knowledge and views in the context of various public consultations made by Member States (Risk Management Option Analysis) and ECHA

Increasing transparency and predictability- Information on ECHA’s website- Direct communication to registrant and notifiers

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Annex VICandidate List

Annex XIVAnnex XVII

Scr

een

ing

CoRAP & substance evaluation

PBT/EDAssessment

RMOA

Potentially subject to

compliance checks

Recommendation for inclusion in

Authorisation List

Public consultation on proposals for:• SVHC• Restriction• CLH

Registry of intentions• SVHC• Restriction• CLH

formal regulatory processespre-regulatory activities

Increased communication

Thank [email protected]

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