Risk management of

chemicals under REACH

Workshop on REACH and EU BiocidalProduct Legislation

Belgrade, 31 May 2012

Rémi Lefèvre

European Chemicals Agency

Implications for non-EU actors

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Content

• Risk Management of Chemicals under REACH• Overview

• REACH Authorisation

• Implications for non-EU actors

Introduction

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REACH Regulation (EC) No. 1907/2006

Registration,

Evaluation

Authorisation and Restriction of CHemicals

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Aim of REACH

Article 1:

• The purpose of this Regulation is to ensure a high level of protection of human health and the environment, including the promotion of alternative methods for assessment of hazards of substances, as well as the free circulation of substances on the internal market while enhancing competitiveness and innovation.

• This Regulation is based on the principle that it is for manufacturers, importers and downstream users to ensure that they manufacture, place on the market or use such substances that do not adversely affect human health or the environment. Its provisions are underpinned by the precautionary principle.

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REACH does not stand on its own (1)

• Other sectoral chemicals legislation exists:• Plant Protection Products - pesticides

• Biocidal Products - biocides

• Other important policy areas where links in terms of chemicals management exist:

•Environment:

• Water (e.g. priority hazardous substances)

• Waste (e.g. use of hazardous substances in electronic equipment)

• Air (e.g. quality objectives, paints directive (solvent use))

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REACH does not stand on its own (2)

• Worker protection legislation:• Framework Directive on Health and Safety at Work

• Setting of occupational exposure limits (OELs)

• Carcinogens and Mutagens Directive

• Consumer Protection:• General Product Safety Directive

• Toys (includes chemical requirements)

• Cosmetics

• Health:• Medicinal products and medical devices

• Food:• Food contact materials

Risk Management of chemicals under REACH

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Risk and Risk Management (1/3)

Chance/Risk = [good/bad event] x [probability it happens]

In REACH world: risk = [hazard] x [exposure]

Example:

Risk of washing metallic pieces with substance X, 7 hours a day, with basic gloves

= 50% probability of getting a skin cancer after 10 years

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Risk and Risk Management (2/3)

• To manage = To direct, to control

To manage a risk = To avoid or lower the risk

• Example: how to avoid/lower the risk of getting a skin cancer because of washing metallic pieces with substance X, 7 hours a day, with basic gloves?Reminder: risk = [hazard] x [exposure]

You can:

�lower the hazard: substitution of substance X by a less hazardous one

�lower the exposure: better protection, lower periods of exposure

�avoid the risk: changing the process so that washing is not needed

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Risk and Risk Management (3/3)

To trigger and decide on the RMMs, one should:

• be aware of a hazard, and assess the risk associated with it (e.g. exposure)• at industry level: know/assess the technical possibilities for reducing/avoiding exposure (incl. alternatives)

• for authorities: know/assess the possible options for regulatory action

• REACH risk management measures aim to control the emissions and exposures at source

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REACH Processes

Industry gathers information and ensures responsible

and well-informedmanagement of the risks

Commission, with support of ECHAand MS-CAs, applies community

wide risk management systems

• Data sharing

• Registration

ECHA and MSCAs control and request for further info MSsMSs

• Evaluation• Dossier evaluation

• Substance evaluation

• Classification & labelling

• Authorisation

• Restriction

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Risk Management in REACH

• Industry (company) level:• Registration (Chemical Safety Assessment)

• Authority level:• Classification and Labelling

• Authorisation

• Restriction

Chemical Safety Assessment

under Registration Process

Requires first level risk management measures at company level

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Registration

Subtitle if necessary• Manufacturers and importers of chemical substances must

register if >1tonne per year

• Exemptions from registration e.g. medicinal products, food or feedingstuffs

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Registration - objectives

Subtitle if necessary• To ensure the safe manufacture and use of chemicals

• To increase knowledge about substances manufactured/used/marketed in the EU

•Generated information transmitted to Authorities and Downstream Users (DU)

•Manufacturers (M) and importers (I) have an obligation to take measures to control identified risks

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Chemical Safety Assessment (CSA)

• A CSA required when a substance is manufactured or imported at 10 tonnes or more per year

• Assess whether risk arising from substance is adequately controlled during manufacture/use and allow others down supply chain can control risks

• The assessment is documented in a Chemical Safety Report (CSR) and submitted as part of a registration dossier

• Annex I of REACH sets out the general provision for assessing the substances and preparing CSRs

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Purpose of CSA & CSR

• Main instrument to carry out and document safe use of chemical

• Assess the intrinsic hazards of substances

• Characterise risks following emission/exposure

• Identify and describe conditions under which risks are controlled

Classification & Labelling

Introduces first level regulatory risk management measures (depending on severity of the hazards)

CLP Regulation – Regulation (EC) No. 1272/2008 Entered into force 20 January 2009

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Classification

• Determine if a substance (or mixture) is hazardous

• Classification criteria• Compare data on substance

(e.g. study results) with criteria

• Decide on appropriate classification

• Based on hazard, not risk• i.e. classify on intrinsic properties of substance

• Harmonised classification: • Agreement of classification at EU level

• Obligatory to use for every manufacture, importer or downstream user of the substance

• List of harmonised classification (CLP, Annex VI, Table 3.1 and 3.2)

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What is Classification & Labelling (C&L)?

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Why do we classify and label?

• Provide information on hazardous properties & control measures aimed at ensuring safe production, transport, use and disposal

• Aim to protect workers, consumers and environment by means of labelling, reflecting possible hazardous effects

• Safety Data Sheet – tool to communicate information to

allow safe use of their substances and mixtures

Authorisation

One of main regulatory instruments available for authorities under REACH to manage risks from chemicals

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Main principles of authorisation (1/2)

• Focus on:• most hazardous substances = Substances of Very High Concern (SVHC)• Carcinogens, Mutagens and toxic for Reproduction: CMRs � Human Health

• Persistent, Bioaccumulative and Toxic for the environment: PBTs � Environment

• very Persistent and very Bioaccumulative: vPvBs � Environment

• Substances of “equivalent level of concern”

• for which uses may lead to significant exposure

• Principle: after a certain date (“sunset date”)

the use of an Annex XIV substance is forbidden

unless specifically authorised (or exempted)

• Ultimate goal: substitution by safer alternatives

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Main principles of authorisation (2/2)

• Some general exemptions:• scientific Research & Development

• all intermediates

• substances for which management of risks for human health and/or environment are already covered by other relevant Community legislation (medicinal products, cosmetic products, food and feed, food contact material, biocides and pesticides, fuels)

• …

• NOT covered by the authorisation requirement:• manufacturing processes

• imported articles containing the substance

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The authorisation procedure:a two-step approach

• Step 1: subjecting substances to the authorisationrequirement

Step 1.1: Identification of SVHCs ���� “candidate list”

Step 1.2: Prioritisation of substance (“recommendation”) and Inclusion in Annex XIV

���� “authorisation list”

• Step 2: authorisation applications and decisions

Public authorities (mainly)

Industry

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Authorisation – Step 1a

• Step 1a: Identification of substance as a SVHCConsequence: substance gets placed on the Candidate List

Substances of Very High Concern (SVHC)

• Carcinogens, mutagens, reproductive toxins (CMRs) cat 1A and 1B

• Persistent, Bioaccumulative and Toxic (PBT)

•Very Persistent and Very Bioaccumulative (vPvB)

• Substances of equivalent concern to the above

Step 1a: Candidate List

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Substances

ECHA website

Examples:

•Phthalates

•Arsenates

•Cobalt compounds

•Lead compounds (pigments)

•(Di)chromates

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Step 1a: Candidate List - Implications

• Directly after inclusion in the Candidate List:• Suppliers of the substance:

� provide their customers with a safety data sheet

• Suppliers of articles containing the substance:

� provide information to allow safe use of the article to customers or to consumers, upon request (45 days!)

• Six months after the inclusion:• Producers/importers of articles have to notify ECHA if their

article contains a substance on the Candidate List

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Authorisation – Step 1b

• Step 1b: SVHC substance on Candidate List gets placed on Authorisation List (Annex XIV to REACH)Consequence: substance becomes subject to authorisation

Must apply for authorisation in order to be able to use that substance after the ‘sunset date’

Step 1b: Authorisation List (Annex XIV)

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Substances

Official Journal(ECHA

website)

Examples:

•Musk Xylene

•MDA

•HBCDD

•Phthalates (DEHP, BBP, DBP)

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Step 1b: Annex XIV listing - implications

• After the « sunset date », industry is not allowed to place an Annex XIV substance on the market for a use or use it unless industry has an authorisation grantedby the Commission

• An authorisation is substance, use and supply-chain specific, but can be applied jointly (M/I/DU(S))

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Authorisation – Step 2

• Step 2: Applications for AuthorisationConsequence: authorisation may/may not be granted

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Step 2: Applications for authorisation

• An applicant can be:

• a manufacturer,

• an importer,

• a downstream user,

• any combination of these.

• An application for authorisation can be submitted:

• for one or several uses

• for one or a «group of» substance(s)

• «an application for authorisation shall be accompanied by a fee» (see Fee Regulation)

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• The Commission shall grant an authorisation if:

risks are adequately controlled (« adequate control route »)

!NB: not applicable for substances with PBT, vPvBproperties and non-threshold CMs

• The Commission may grant an authorisation if:

socio-economic benefits outweigh the risks

and

there are no alternatives available that (1) reducethe overall risk and (2) are technically and economically feasible for the applicant(s)

(« socio-economic route »)

When will an authorisation be granted?

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The two routes for authorisation

Application

Authorisationgranted

YES

AuthorisationNOT granted

NO

Risksadequatelycontrolled?

Socio-economicbenefits >

Risks?

NO

Adequatecontrol route

Socio-economic

route

Alternatives?

YES

YES

NO

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Authorisation decisions

• An authorisation is substance, use and supply-chainspecific

• Commission decisions will specify:• the identity of the substance(s)

• the person(s) to whom the authorisation is granted

• the use(s) for which it is granted

• any conditions under which it is granted, incl. any monitoring arrangement

• a time-limited review period (case-by-case approach)

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The authorisation overall procedure

MSC

EC

EC

EC

AnnexXV

dossier

Step 1.1: Identifying SVHCs Step 1.2: Subjecting prioritysubstances to authorisation

Step 2: Granting (or not) authorisation

Candidate List

AnnexXIV

Application

MSC

Authorisationdecision (OJ)

ca. 5 months

Prioritisation

draftrecom-

mendation

ca. 6 + 12 months

recom-mendation

Public consultation

up to 2 years

Public consultation

Public consultation

RAC SEAC

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Impacts of Listings

• Legal obligations:

• Candidate List:• Substance in Articles Notification (Article 7(2)): EU producers and importers of articles shall notify substances in articles to ECHA

• Communication to supply chain/consumers (Article 33)

• Annex XIV (« Authorisation List »):• Application for autorisation for continued use

• Market forces for substitution

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Further general information on authorisation

• About the process, steps and actors:

http://www.echa.europa.eu/web/guest/regulations/reach/authorisation

• About the different lists, opinions/decisions, and public consultations:

http://www.echa.europa.eu/web/guest/addressing-chemicals-of-concern/authorisation

• About the practical details of dossiers developmentand submission:

http://www.echa.europa.eu/web/guest/support/authorisation

Restriction

Other main regulatory instruments available for authorities under REACH to manage risk to chemicals

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Restrictions: aim and scope

• Ensure protection of human health and or the environment, where• Manufacturing, placing on the market or use causes unacceptable risk

• These risks need to be addressed on Community-wide basis

• Ensure good functioning of the internal market

Can cover • any substance on its own, in mixtures and/or in articles• manufacturing of substances • Import of articles containing substance

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Restrictions

• All restrictions listed in Annex XVII• Full ban or ban on certain uses

• Certain derogated uses

• Specific conditions of use

• Obligation to:• comply with any conditions set out in Annex XVII

• Update Safety Data Sheet

Authorisation vs. RestrictionComparison of the tools

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Relationship between Restrictions and Authorisation

Authorisation on Annex XIV

Restrictions on Annex XVII

General exemptions

Grantedauthor.

Restricteduses

= forbidden/restricted = not restricted/authorised

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Comparison

Restriction

• Applies directly, to all

• Can be

- full ban of a substance or

- ban of specified usesand/or

- condition on the specified uses

Authorisation

• After a given date uses of a substance are bannedunless specificallyauthorised � specific individual authorisation process

• Case-by-case conditions

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Comparison – objectives and background

Restriction

• Avoid or reduce identifiedrisk to human health or the environment

• Ensure functioning of the internal market

• Started in 1976, experience on introducing new ones and on enforcement

• Knowledge on difficulties and weaknesses

Authorisation

• Promote substitution

• Assure that risks related to SVHCs are properly controlled

• Ensure functioning of the internal market

• New regulatory tool, little experience

• High expectations

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Comparison - scope

Restriction

• Any substance causing unacceptable risk

• Manufacture, placing on the market and/or use

• Substance on their own, in mixtures and/or in articles

• Flexible, case by case design

Authorisation

• SVHCs only

• Placing on the market for a use and/or use

• Substance on their own and in mixtures

• Authorisation requirement on all uses (within the scope of authorisation)

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Risk Management under REACH - Summary

• Chemical Safety Assessment• First level risk management measures at company level

• Classification and Labelling• Introduces first level regulatory risk management measures (depending on severity of hazards)

• Authorisation & Restriction• Main regulatory instruments available for authorities under REACH to manage risk to chemicals at EU level

• Complement each others

• Authorisation is a complex and totally new process: we are all learning by doing!

Implications for non-EU actors

How to prepare for EU customersrequirements?

Articles

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Definition of “Article” (REACH Article 3(3))

�An object which during production is given a special shape, surface or design which determines its function to a greater degree than its chemical composition

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Substance, mixture or article?

Paintin pot

Spraycan

Fire cracker

Thermo-meter

Carbattery

Perfumederaser

SubstanceMixture Article

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Obligations for EU importers/producers of articles

From Registration:

1. Registration of substances in articles intended to be released (Article 7(1))

From Candidate List:

2. Notification of substances in articles, under certain conditions (Article 7(2))

3. Communication in the supply chain (Article 33)

From Restriction (Annex XVII):

4. Comply with existing restrictions

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Notifications of substances in articles (Article 7(2))

• EU Producers and importers of articles shall notifysubstances in articles to ECHA if

• The substance is on the Candidate List, and

• The substance is present in the articles at a total of >1 tonneper producer/importer per year, and

• The substance is present in those articles above a concentrationof 0,1% weight by weight.

• Companies shall notify to ECHA within 6 months of the inclusion of the substance on the Candidate List (Next deadline: 19 June!) or when starting import/production.

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Communication requirements(Article 33)

• Article 33(1): When there is >0.1% of a Candidate List substance in the article, the supplier of the article: “…shall provide the recipient of the article with sufficient information to allow safe use of the article including, as a minimum, the name of the substance”

• Only for substances on the ‘Candidate List’

• There is no exemption for uses already registered

• No tonnage limit (i.e. also applies below 1 tonne/year)

• Article 33(2):

• Consumers can request the same information. The information should be provided within 45 days, free of charge.

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Relevant actors for substances in articles

• Importers and producers of articles in EU• Has to fulfil legal obligations in order to put an article on the EU market

• Only Representatives• can be appointed by a non-EU producers of article

• take the role of importers

• Non-EU suppliers/producers of article• Can/should support the importers by providing information

• Suppliers of chemical substances• Can provide information to the non-EU article producers

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How to prepare for EU customers’ requirements

• Make an inventory of the articles you export to EU

• Find out which hazardous substances they contain

If you do not produce the article yourself

• For efficient communication with your supplier, try to find out which substances are most relevant to ask your supplier about

• Start e.g. by identifying the materials contained in the different articles

• Depending on the materials, certain Candidate List substances are more likely to be present than others

• Try to anticipate the requests• Does the article contain > 0.1% of a Substance of Very High Concern (SVHC) (i.e. Substances on the Candidate List)?

• Is there intentional release of a substance from the article during normal and reasonable foreseeable conditions for use?

• If yes, how much of that substance is contained in the article?

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Customer requirements may go furtherthan REACH…

• Does your article contain Candidate List substances (at all!)?

• Is your article ’REACH compliant’?• Make sure you mean the same thing by ’REACH compliant’

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Effects of Authorisation List (Annex XIV) on non-EU suppliers

• NO DIRECT IMPLICATION: imported articles are not subject to the authorisation application requirement

• After the sunset date, ECHA shall consider whether the use of an Annex XIV substance in articles poses a risk that is not adequately controlled. If so, ECHA shall prepare a restriction proposal. A restriction will apply also to imported articles

• Non-EU suppliers are thus recommended to follow the authorisation applications and consider substitution at an early stage allowing for a smooth transition to alternatives

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Effects of Restrictions (Annex XVII) on non-EU suppliers

• Substances in articles may be subject to restrictions

• Examples:• Cadmium content in plastic materials (entry 23)

• Nickel in articles intended to come into direct and prolonged contactwith the skin (entry 27)

• Azocolourants in textile and leather articles (entry 43)

• Penta- and octa-BDE in articles (entries 44-45)

• 6 phtalates in toys and childcare articles (entries 51-52)

• Dibutyl- and dioctyltin compounds in consumer articles (entry 20)

• Make sure your articles are in line with these restrictions!

Substances and preparations

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Obligations for EU importers ofsubstances on their own or mixtures

From Registration:

1. Registration requirement

From Candidate List:

2. Provision of Safety Data Sheets (SDS) to EU downstream users (Art. 31(1))

From Authorisation List (Annex XIV):

3. Authorisation requirement

From Restriction (Annex XVII)

4. Comply with existing restrictions

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Other impacts of Candidate Listing

• Market pressure and opportunities

• « On the way to substitution »

Conclusions

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Be aware, be ready!

• EU importers have legal obligations� non-EU suppliers can/should provide information to meet their needs

� being ready to provide EU customers with the information theirneed/require can be a (pro-active) way to secure markets

• Market forces: EU customers may go further in their requirements (e.g. “no SVHCs in articles!”)

• Be prepared• Make inventories

• Keep track of EU regulatory developments (Candidate List, Authorisation List, Restrictions – Annex XVII)

• Consider substitution

• Actively communicate up and down the supply chain

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Plan for the future

• Do not wait - start collecting and assessing data now

• Get ”early warnings” via Registry of Intentions (RoI)http://echa.europa.eu/web/guest/addressing-chemicals-of-concern/registry-of-intentions

• Sign up for ECHA’s News Alerts (for updates of RoI, C&L Harmonisation proposals, Restriction proposals, SVHC proposals and Candidate Listing,…) http://echa.europa.eu/news_en.asp

Thank you for your attention.

Rémi Lefèvre

remi.lefevre@echa.europa.eu