ECHA’s focus on improving the information in the supply chain

Jack de Bruijn

Director Risk ManagementEuropean Chemicals Agency

Kemiens Dag, København21 November 2013

Contents• The aims of REACH• State of play in 2013• How to improve quality of

registration information• How to improve quality of

information in the supply chain

• Conclusions

Back to the basics of REACH

Main Problems with previouschemicals legislation

• Data gaps: 86% of HPVCs have less than base set data

• The process took (far) too much time• Burden of proof was on public authorities• Generally Downstream Users stayed out of the

picture, actual uses of chemicals remain unknown• The system was inefficient and the administrative

burden for new, mostly low volume, chemicals prevented innovation

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Protecting Human Health and the Environment

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How in general to achieve the health and environment objective?

• Better knowledge on properties and uses• Better safety and control measures• Reducing exposures and hence negative impacts• Replacing (gradually) hazardous substances

with less hazardous ones

• Key legislative drivers: Registration, Supply chain communication, Authorisation and Restriction

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Shifting the burden of proof

• REACH is based on the principle that industry should manufacture, import or use substances with such responsibility and care as may be required to ensure that, under reasonably foreseeable conditions, human health and the environment are not adversely affected

• Companies handling chemicals should take the necessary risk management measures in accordance with the assessment of the risks of substances and pass on relevant risk management recommendations down the supply chain for all supported uses

8echa.europa.eu

Registration dossier

C&L (GHS)

Safety Data Sheet

Exposure Scenarios

+

Chemical Safety Report Exposure Scenarios

+

Safety advice

Manufacturers-Importers

Information on uses

Customers (Downstream Users)

Public

ECHA – EU Authorities

Responsibility shifted to industry

State-of-play

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Progress• Two registration deadlines passed – 2010 - 2013

• Substances over 100 tpa; CMRs over 1tpa • Data on > 11 000 substances from over 41 500 dossiers (>

2 million study summaries on properties and effects of chemicals)

• Classification and Labelling Inventory• EU harmonised classification for ~4 500 of substances and

Classification for > 110 000 substances (> 6 million notifications)

• Information published on ECHA website• Eurostat study five-year update revealed a “marked

increase in quality of data & better control of risk”

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Compliance?• 1000 dossiers will have been checked by end 2013• Covering ~30% substances registered by 2010• But - many registrations found to be

non-compliant• Unclear substance identification in many cases• Improving compliance is a key objective of ECHA

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Quality ?

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Quality is essential• It proves that chemical companies have assumed

their responsibilities as required by REACH• Reliable data are needed to make a responsible risk

assessment and to recommend adequate safety measures

• Registration information is the basis for Authorities to judge whether risks are adequately controlled or there is a need for more regulatory actions

• It creates public confidence!

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Commission REACH review on supply chain communication• Increased information on substances is resulting in

changes on classification (mostly more stringent) and improved risk assessments

• Increased info in supply chain and improved safety data sheets results in more appropriate risk management measures

• Nevertheless……... ECHA and Industry are encouraged to address the problems related to compilation, communication and use of extended SDSs and promote them as a central risk management tool

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Further findings• eSDS not yet widely used• Confusion still exists about:

• use descriptors• short titles of ESs• length and level of detail needed, info in ESs vs main

body of the SDS • SDS for mixtures• Best way to communicate safety advice to ‘end-users’• Integration of HH and ENV aspects

• Requirements for substances in articles not generally known in the retail sector

How to improve quality of registration information

ECHA’s strategic objective 1: Maximising high quality of informationThree pillars:

• Increase the compliance and quality of the information and safety assessment generated for REACH & CLP purposes

• Facilitate the transfer of risk management information within the supply chain (via SDS and exposure scenarios)

• Ensure that information published on the ECHA website is easily accessible and understandable by all stakeholders, incl. the public and strengthen the transparency

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Quality: ECHA’s strategic objective

ECHA

Submission time

Regulatory actions

Completeness check

Post submission

Quality Control

Systematic screening

Dissemination

Industry

Prior submission

Supportactions

GuidanceIT tools

WebinarsFeedback

Interaction

ECHA & MS

Regulatory actions

Compliance check

Enforcement

Evaluationactivities

Areas of action to affect quality

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ECHA’s approach: Find the right action to maximise impact• Development of methods and tools to systematically

analyse all information received. Examples:• Targeted compliance checks: Find all dossiers with a specific

issue and send a legal decision to all registrants concerned• Screenings based on automated analysis followed by a

“friendly” letter, registrants are offered tailor-made advice on how to improve the dossier before ECHA starts legal actions

• 2013: focus on substances registered as intermediates• 2014: focus on substance identification

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Be proactive !• Registration is not the end of the process• Keep information up-to-date

• Read the Evaluation reports reflecting dossier quality findings

• Update the dossiers before receiving formal feedback from ECHA

• Be prepared (within the joint submission) for requests for updates from ECHA, e.g. screening letters, Evaluation decisions

09 October 2013

How to improve quality of information in the supply chain

ECHA’s strategic objective 1: Maximising high quality of informationThree pillars:

• Increase the compliance and quality of the information and safety assessment generated for REACH & CLP purposes

• Facilitate the transfer of risk management information within the supply chain (via SDS and exposure scenarios)

• Ensure that information published on the ECHA website is easily accessible and understandable by all stakeholders, incl. the public and strengthen the transparency

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Extended safety data sheet – tool for communication

• Registered Uses• Include DNEL’s and PNECs if

available• Summary of Risk Management

Measures from Exposure Scenarios

Main body Exposure scenarios

– Use-specific operational conditions

– Use-specific risk management measures

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Life cycle approach – number of ESs attached

• The entire life cycle of a substance is covered by ESs – from manufacturing, through formulation to end use and waste – End-uses - substance

• Use by workers at industrial sites• Use by professional workers• Consumer use

– Service life - article• by workers at industrial sites• by professional workers • by consumer

Manufacturing

Formulation

End use

Waste

Formulation

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Our response – I: Exchange Network on Exposure Scenarios (ENES)• Joint initiative with Cefic, Eurométaux, CONCAWE,

Fecc and A.I.S.E. • Participants: manufacturers, downstream users,

industry associations, Member State competent & enforcement authorities and European Commission

• Aims to identify good practices on preparing and implementing exposure scenarios, and to develop an effective communication exchange between supply chain actors

http://echa.europa.eu/web/guest/about-us/exchange-network-on-exposure-scenarios

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Our response – II: The CSR/ES roadmap• Roadmap towards good quality information on

the safe use of chemicals in the REACH chemical safety report and the extended safety data sheet.

• Action plan towards 2018 with medium- and long-term orientation

• Two main elements:• Exposure scenarios in the Chemical safety report• Exposure scenarios annexed to the (extended) safety

data sheet

http://echa.europa.eu/csr-es-roadmap

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Summary of key actions • Short term (practical/methodological) issues to solve;

• Short titles of ESs• Effective link between CSA and ESs (eg. through Chesar)• Guidance and exemplifying safe use information for mixtures

• Medium-term;

• Harmonisation/standardisation of safety phrases• Improve communication to end-users

• Long-term perspective; • Facilitate the effective use of REACH information by DUs to

comply with their obligations under other legislation

Roles in the chemicals supply chain

Manufacturer of substancesCarries out the Chemicals safety

assessment

Producer of mixturesIntegrates safe use measures into the

product design

Industrial and professional user of chemicals

Implements conditions of safe use

ECHADemonstrates control of risk for all uses in the CSR submitted to authorities

Communicates mixture characteristics and conditions of safe use

Trade & Sector associationsCollect and consolidate information on current conditions of use; inform suppliers.

Communicates substance characteristics and conditions of safe use

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Need for cooperation!• ECHA is determined to support DUs with development of necessary

methods, tool and formats but………• Optimal supply-chain communication is really a matter for industry

sectors• Knowledge on uses• Knowledge on risk management• Knowledge on how best to communicate

• Crucial that sector organisations at national level become involved and take actions to ensure that the results at European level are percolated to the right companies

• DU should accept their responsibility in terms of requesting good quality information from their suppliers, and hence protect their business and long term interests

Vision for REACH 2020 in practice

echa.europa.eu

• Supplier • Formulator • User

• Increased information down the entire supply chain• Methodologies regarding mixtures are developed• Formulators use effective systems for handling information• Good communication between suppliers, formulators and users

results in improved business environment

.. Helps to protect human health and the environment

Conclusions

• REACH registration is living up to expectations, but quality of information needs improvement

• Companies need to keep their dossiers up-to-date and are advised to proactively improve the information

• Supply-chain communication and DU obligations are key to the success of REACH

• Problems have been recognised, an action plan has been set up and first actions have been taken

• Need for cooperation on implementation methods and tools at EU and national sector level

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Tak!jack.de-bruijn@echa.europa.eu

Use chemicals? Use them safely!

http://echa.europa.eu/downstream