Klicken Sie, um das Titelformat zu bearbeiten TÜV Product Service Ltd © Open Day 24 June 2010 Phil Dolling REACh: What is it and how does it affect you?

Klicken Sie, um das Titelformat zu bearbeiten

TÜV Product Service Ltd © Open Day 24 June 2010 Phil Dolling

REACh: What is it and how does it affect you?

Phil Dolling



Content

• What is the REACh Directive and why was it introduced?

• Responsible Authorities

• Main features of the Directive

• How REACh affects supply chain actors

• Coping with REACh

• Useful websites

• Top Tips



What is the REACh Directive?

• European Union regulation (EC) No. 1907/2006

• Registration, Evaluation, Authorisation & restriction of Chemicals.

• Came into force on the 1st of June 2007

• Replaces a number of European Directives and Regulations with a single system.



Why was the Directive introduced?

• Protect human health and the environment

• Understand and manage the risks associated with chemical use.

• Free movement of substances (chemicals) in the EU

• Chemicals industry - enhance innovation in / competitiveness of

• Alternative methods for the assessment of the hazardous properties



Responsible Authorities

European Chemicals Agency (ECHA), Helsinki

• European database for registration of chemicals

• Co-ordinates the in-depth evaluation of suspicious chemicals

• Public database in which consumers and professionals can find hazard information http://apps.echa.europa.eu/registered/registered-sub.aspx

http://apps.echa.europa.eu/registered/registered-sub.aspx




UK REACH Competent Authority

Health and Safety Executive (HSE)

• Enforcement of compliance (includes use of RAPEX)

• Evaluate selected substances

• Provide helpdesk

• Identify substances of very high concern




The Rapid Alert System for Non-Food Products (RAPEX)

• EU rapid alert system for dangerous consumer products

• Exchange of information between Member States and the Commission

• http://ec.europa.eu/consumers/dyna/rapex/rapex_archives_en.cfm

http://ec.europa.eu/consumers/dyna/rapex/rapex_archives_en.cfm







HSE Cannot:

• Respond to complaints about the operation of REACH at the European level

• Provide input to any assessments being conducted by industry

(to avoid conflict of interest)

• Give views/opinions on draft assessments

• Provide support on policy issues



Main features of the Directive - R

Registration - substances

• Manufacturers / importers - register substances with ECHA

provide a standard set of data

(proportionate to use)

• No registration, no data available, no legal manufacture / supply

• Therefore NO data, NO market!




Registration - Articles

• “Articles” - a special registration regime

• Any object that has been given a specific shape, surface or design so that it can be used for a specific purpose

(e.g. cars, textiles, electronic chips, chair)

• Substances that are intended to be released from articles during use

(≥ 1 tonnes per annum (tpa) per producer / importer)




Additionally for Articles

• Substances of very high concern (SVHC) in articles - notify ECHA

(≥ 0.1% (w/w) and ≥ 1 tpa and NOT yet registered for that use)

• Suppliers of articles containing SVHC - pass on sufficient information to recipients to allow safe use

(≥ 0.1% (w/w) )




Registration timeline:

1 December 2010

Deadline for registration of substances supplied at ≥ 1000 tpa

1 June 2013


1 June 2018





Notification process – Articles only

Not necessary if:

• Already registered for that use• Exposure to humans or environment can be excluded during use &

disposal (unmanned satellite?)

• Note: 0.1% limit applies to entire article (e.g. car, engine)




Notification process – Articles only

• Typical notification:

company details, identity of substance, classification and labelling, use in article and use of article

• ECHA may review and subsequently require a registration

• Process starts 1st June 2011 (or thereafter 6 months after inclusion on candidate list)



Main features of the Directive - RE

Evaluation of Data

• Compliance checking – sampling check of the quality of information submitted by industry

• Dossier Evaluation – A testing proposal must be submitted to avoid unnecessary animal testing

(substances registered at ≥100 tpa only)

• Substance Evaluation – restrictions on manufacture, supply or use? (possible SVHC classification and addition to Candidate List)




Substances of Very High Concern (SVHC)

• Hazards with serious consequences (cancer, toxic for reproduction, remain in the environment, amounts in animals gradually increasing)

• Currently there are 38 SVHC on the Candidate List and can be found at:

http://echa.europa.eu/chem_data/authorisation_process/candidate_list_table_en.asp

http://echa.europa.eu/chem_data/authorisation_process/candidate_list_table_en.asp




Candidate List

Substances in Articles

• From date of inclusion on Candidate List

Information to customers to allow safe use

(≥ 0.1% (w/w))

Information to a consumer upon request (substance name minimum) (45 days)

• From 2011

Notify ECHA if article contains a substance on the Candidate List.

(≥1 tpa and concentration ≥ 0.1% (w/w))




Candidate List

Substances on their own

• From date of inclusion on Candidate List

EU/EEA suppliers of substances on the Candidate List have to provide their customers with a safety data sheet

(see Article 31 and Annex II of REACh Directive for SDS requirements)



Main features of the Directive - REA

Authorisation

• Some SVHC will eventually require authorisation

• ECHA recommend SVHC to European commission

• “Annex XIV” list.

• Authorisation for specific uses now required.

• “sunset date” - prior authorisation required



Main features of the Directive - REACh

Restrictions of Chemicals

• Any substance on its own, in a preparation or in an article if it is demonstrated that risks need to be addressed on a Community-wide basis.

• Restrictions regulates the manufacture, placing on the market or use of certain substances if they pose an unacceptable risk to health or the environment.

• Activities may be limited or even banned



How REACh affects supply chain actors

Actors & duties

Any natural or legal person established within the community who:

• Manufacturer - manufactures a substance within the Community

• Producer of an article - makes or assembles an article within the Community

• Importer - responsible for import of substances and articles

Duties may include registration, notification or communication to customers. “Due diligence”




• Downstream users - substance used for industrial or professional activities. Not a distributor or a consumer

Examples:

formulators of preparations (paints), users of chemicals in industrial processes (oils), professional users (car repair shops) or producers of articles (e.g. electronic components, toys).

Duties include:• Making uses known to suppliers (helps the supplier prepare an SDS)• Preparing reports for uses outside suppliers SDS conditions. This

use must also be reported to ECHA. (≥1 tpa)




• Distributor of substances - only stores and places on the market a substance, on its own or in a preparation for third parties (includes retailers)

Duties include: • Supply safety information with the substances it sells.

Can be a Safety Data Sheet (SDS), an Annex of which is reserved for any exposure scenarios developed.




• Supplier of an Article - Any producer or importer of an article, distributor or other actor in the supply chain placing an article on the market (such as a retailer)

Normally has no legal obligation to communicate via an SDS.

Has obligations under Article 33 to forward information on the content of SVHCs on the candidate list to customers and consumers (general public).



Coping with REACh

• Understand your role

Manufacturers/Importers, Downstream users, distributor of substances, supplier of articles

• Compile an inventory

All chemicals that come into, are part of, or go out of your business

Name, percentage in any preparation, tonnage per year

Articles - establish if any substance intended for release is present in quantities totalling over 1 tonne. Know SVHC content.



Coping with REACh

• Prioritise

Consider the importance of each chemical to your business and talk to suppliers about continuity of supply as REACh takes effect.

• Build relationships

Identify a person in your company to be the main REACh contact and gather information from suppliers and customers



Coping with REACh

• Spot check chemical testing

Periodically check imported articles for SVHC’s. This can be part of a regular audit process and keep suppliers alert to the REACh requirements.

Analysis of 38 substances of very high concern on the Candidate List for authorization. Determines whether each of the 38 SVHC <0.1% (w/w).

TÜV Product Service has laboratories capable of this testing in China, Hungary and Munich.



Useful websites

European Chemicals Agency (ECHA)

• http://echa.europa.eu/reach_en.asp

Health and Safety Executive (HSE)

• http://www.hse.gov.uk/reach/index.htm

http://echa.europa.eu/reach_en.asp

http://www.hse.gov.uk/reach/index.htm



Top Tips

• Implement a robust quality system with regard to REACh

• Compile a technical file

• Audit suppliers

• Spot-check chemical testing



Top Tips

Choose certainty.

Add value.



THANK YOU

Documents

Klicken Sie, um das Titelformat zu bearbeiten TÜV Product Service Ltd © Open Day 24 June 2010 Phil Dolling REACh: What is it and how does it affect you?