The European experience on implementing REACH for chemicals risk management An overview

Jack de Bruijn Director Prioritisation and Integration European Chemicals Agency Helsinki

Contents

•  Chemicals and sustainability •  The EU ’system’ •  Basic principles of REACH/CLP •  Results after 12 years of

REACH •  Recommendations

Effects of chemicals

•  WHO estimated the burden of disease from selected chemicals at 1.6 million lives in 2016

•  Foetuses, infants, children, pregnant women, elderly and poor among the most vulnerable

•  Chemical pollution threatens ecosystem services (e.g. pollinators, coral reefs)

•  Costs of inaction and benefits of action estimated to be significant (high tens of billions annually) Deaths  (total:  1.6  million)  a3ributed  to  selected  

chemicals  in  2016  (WHO    2018)  

Overall growth expected to continue

Source: CEFIC

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Chemicals in a circular economy

•  Materials in the waste stage consist of chemicals

•  Globally traded articles may contain substances of concern – potential issue when recycled

•  Identification of chemicals of concern needed at global level

•  Systematic communication throughout the global supply chain including waste operators

The Sustainable Development Goals

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The EU ’system’ of chemicals management

The EU ’system’ in simplified version

Classification, labelling & packaging (CLP)

Industrial chemicals (REACH)

Pesticides Biocides Pharma-ceuticals

Transport, major accidents

Worker Protection

Consumer Protection

Environmental protection

(air, water, soil, drinking water,

industrial emissions)

Waste legislation

(waste, waste water, shipment, packaging)

Product legislation (cosmetics, food contact

materials, toys, electronics)

General/ International

(Ecolabel, ecodesign, POPs, PIC)

REACH

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A lengthy legislative journey

Low volume substances

(1 to 100 tonnes)

Notification new

substances

Medium volume substances

(100 to 1000 tonnes)

Existing substances

Dangerous substances directive

(classification)

2018 2013 2008 2007 1993 1981 1967 2010

Most hazardous and commonly

used substances (1000 tonnes or above)

CLP

Basic principles of REACH and CLP

REACH: Registration, Evaluation, Authorisation and Restriction of Chemicals

CLP: Classification, Labelling and

Packaging of substances and mixtures,

Industry responsibility

Art 1: The purpose of this Regulation is to ensure a high level of protection of human health and the environment,……, as well as the free circulation of substances on the internal market while enhancing competitiveness and innovation. Art 3: 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.

REACH and CLP – main processes and actors

Registration Self-classification

Industry gathers information and ensures adequate risk management throughout the supply chain

Authorisation Restriction Harmonised C&L

Commission, supported by ECHA and MSCAs, applies EU wide risk management measures

ECHA and MSCAs screen and check the data and request more if needed

Evaluation Member States

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Registration

•  Manufacturers and importers obtain information on their substances

•  Use this knowledge to ensure responsible and well-informed management of the risks these substances may present

•  Document this in their Registration Dossier (in IUCLID)

•  Submit it to the authorities (fee-based) No formal acceptance - industry retains responsibility

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Information requirements

•  General information (substance ID, volume, uses, C&L, company ID etc)

•  Physical-chemical properties (e.g. solubility, vapour pressure)

•  Fate properties (e.g. (bio)degradation, partition coefficients)

•  Toxicity properties (e.g. acute toxicity, irritation, mutagenicity, carcinogenicity, reproductive toxicity)

•  Ecotoxicity properties (e.g. toxicity to aquatic or terrestrial organisms)

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Tonnage dependent requirements and deadlines Tonnage Annex Deadline

> 1 tonnes per year VII 2018

10 - 100 tonnes per year + VIII + CSR 2018

100 - 1 000 tonnes per year

+IX +CSR 2013

>1000 tonnes per year +X +CSR 2010

CSR: Chemical Safety Report (~ risk assessment) covering all uses of the substance

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Chemical Safety Assessment (CSA)

•  Carried out by the registrant and submitted with the registration dossier (CSR)

Aims to: •  Characterise the environmental and health hazards:

•  Classification, No-effect levels •  Characterise the potential exposure to humans and the

environment •  Full life cycle (manufacture, formulation, use, service life, waste) •  Workers, consumers, general public (incl. sensitive populations)

•  Determine the conditions under which the substance can be used safely

•  Communicate these conditions with SDS to all the commercial users of the substance

REACH and CLP – main processes and actors

Registration Self-classification

Industry gathers information and ensures adequate risk management throughout the supply chain

Authorisation Restriction Harmonised C&L

Commission, supported by ECHA and MSCAs, applies EU wide risk management measures

ECHA and MSCAs screen and check the data and request more if needed

Evaluation Member States

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Evaluation

•  Evaluation is the regulatory process to ensure that registrants provide the information that is needed: •  For legally complying with the legislation •  For clarifying a concern

•  Typical outcome of evaluation: ECHA decision to request further studies / information

•  Authorities typically use this information to initiate regulatory action

REACH and CLP – main processes and actors

Registration Self-classification

Industry gathers information and ensures adequate risk management throughout the supply chain

Authorisation Restriction Harmonised C&L

Commission, supported by ECHA and MSCAs, applies EU wide risk management measures

ECHA and MSCAs screen and check the data and request more if needed

Evaluation Member States

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Risk management: authorisation

•  Used for substances of very high concern (SVHCs) identified on the ‘Candidate List’

•  Aim is to progressively replace these by suitable alternative substance or technologies

•  Once prioritised and placed on the Authorisation List, the substance can only be marketed or used after ‘sunset date’ if industry submitted a dossier which has been authorised by the European Commission (based on ECHA opinion)

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Risk management: restrictions

•  When unacceptable risks to humans or the environment have been identified by Member States or ECHA (working on behalf of the European Commission)

•  MS or ECHA develop a proposal •  European Commission decides based on an

ECHA opinion •  Annex XVII of REACH lists all restrictions

(currently 73 entries)

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Annex XVII: Restrictions – Example 1

Polychlorinated terphenyls (PCTs) (entry 1): •  Shall not be placed on the market, or used as

substances, in mixtures, including waste oils, or in equipment, in concentrations greater than 50 mg/kg (0,005 % by weight)

à In effect a full ban on the use

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Annex XVII: Restrictions – Example 2

1,4-dichlorobenzene (entry 64):

Shall not be placed on the market or used, as a substance or as a constituent of mixtures in a concentration equal to or greater than 1 % by weight, where the substance or the mixture is placed on the market for use or used as an air freshener or deodoriser in toilets, homes, offices or other indoor public areas.

Classification and labelling

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Classification and labelling

•  First step to define the hazards of substances and mixtures and thus to ensure that they are manufactured, used and disposed of safely

•  CLP Regulation implements the UN GHS classification criteria

Hazard Classification, Labelling and Packaging

•  The hazard of a substance is the potential for that substance to cause harm

•  Where the nature and severity of an identified hazard meets the classification criteria, hazard classification a standardised description of this hazard is assigned

à E.g. irritating to eyes, cat 1A carcinogen, acute aquatic hazard

•  Hazard labels (to be put on packages) are used to alert the user to the presence of a hazard and the need to manage the associated risks

à e.g. substance causes serious eye irriation, may cause cancer, is very toxic to aquatic life

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Hazard pictogram

Product Identifier

Signal word

Supplier Information

Hazard and precautionary statements

(personal protection,

waste handling, first aid etc)

Classification impacts risk reduction measures under other legislation

Classification

Working environment

Pesticides & biocides

Hazardous waste

Storage and transport

Labelling &SDS

REACH SVHC

Restrictions

Cosmetics

About 20 different legislations relate to CLP for triggering

directly or indirectly risk management measures

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Annex XVII: Restrictions – Example 3

CMRs (substances classified as carcinogenic, mutagenic or toxic to reproduction) (entries 28-30):

1. Shall not be placed on the market, or used,

•  as substances, •  as constituents of other substances, or, •  in mixtures, for supply to the general public •  …suppliers shall ensure before the placing on the market that the

packaging of such substances and mixtures is marked visibly, legibly and indelibly as follows: ‘Restricted to professional users’.

Communication in the supply chain

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Communication in the supply chain

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The safety data sheet (SDS)

REACH defines: •  When a SDS must be provided •  What a SDS should contain •  When exposure scenarios should be annexed •  What to do when companies receive a SDS

•  Classification and labelling information must be provided in accordance with the CLP Regulation

The international perspective

•  Most testing done according to OECD test guidelines and under GLP

•  CLP implements the UN/GHS system •  IUCLID, the tool for recording, storing,

submitting and exchanging data on chemical substances follows the format of the OECD Harmonised Templates

•  Our data is disseminated via ECHA website and the OECD eChemPortal

Results after 12 years of REACH

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We know which substances are used!

Tonnage Registrations Substances

1 000 tonnes and more 19 930 2 195

100 - 1 000 tonnes per year 12 706 3 419

10 - 100 tonnes per year 12 672 4 019

0 - 10 tonnes per year 16 108 5 649

Intermediate 13 447 6 563

Complete (unique substances) 89 751 21 470

Do we know more?

Substances of Very High Concern 201

580 Risk management proposals

1 800 Dossiers for HPV chemicals checked for compliance

147 000 Substances classified with GHS

>2 million Study summaries on properties and effects of chemicals

22 000 Substances registered under REACH

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Commission 2018 REACH evaluation: Key findings (1) •  REACH has significantly improved the protection

of human health and the environment, promoted alternatives to animal testing, and ensured the free movement of chemicals on the EU market.

•  REACH contributes to the EU meeting the World Summit Sustainability Development 2020 goal.

•  REACH evaluation concludes that: •  Legal requirements and obligations well tuned to needs

and objectives. •  A number of actions identified to further improve REACH. •  But currently no need to change its enacting terms.

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Commission 2018 REACH evaluation: Key findings (2) •  Costs seem to be justified by expected benefits

which have started to materialise: •  Main direct costs: registration and the

communication of information along the supply chain (estimated EUR 2.3-2.6 billion for the first two registration deadlines). Additional costs result from evaluation, authorisation and restrictions.

•  The estimated scale of potential benefits for human health and the environment remains in the order of EUR 100 billion over 25-30 years.

Source: https://ec.europa.eu/growth/sectors/chemicals/reach/review_en

Recommendations

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Recommendations (If one would start from scratch)

•  Basic legislation that ensures registration of all substances and places the burden of proof on industry

•  Classification, labelling and packaging (GHS) •  Duty to provide a Safety Data Sheet •  Specific restrictions (making use of what is

available worldwide) •  Enforcement •  Capacity building at industry and authorities

(hazard and risk assesment)

Thank you!

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ECHA 12 years

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•  Operational since 1 June 2007 •  Based in Helsinki, Finland •  Modern, science-driven

regulatory agency •  Performs technical and scientific tasks

that enable the EU to implement legislation and take policy decisions

Mandate: •  Originally REACH Regulation •  Classification, Labelling & Packaging

Regulation (CLP) •  Biocidal Products Regulation (BPR) •  Prior Informed Consent Regulation (PIC) •  Waste Framework Directive (WFD)

Managing industrial chemicals - Main steps

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• Inventory, notification, import/export control, registration Market awareness

• Volume and uses • Hazard and exposure

Availability of information

• Classification and labelling (GHS) Identification of potential hazards

• Identification of substances of concern Priority setting

• Generation of further information, assessing safe use Risk assessment and bridging data gaps

• Restriction, authorisation • May include alternatives assessment, socio-economic analysis

Regulatory risk management

• Checking industry compliance, control of imported goods Enforcement

The UN Global Chemicals Outlook II

1.  The global goal to minimize adverse impacts of chemicals and waste will not be achieved by 2020.

2.  While many chemicals are important for sustainable development, trends are a cause for major concerns, requiring urgent action.

3.  Solutions exist, but more ambitious worldwide action by all stakeholders is urgently required.

4.  Business-as-usual is not an option! https://www.unenvironment.org