1. REACH Regulation (EC) No.1907/2006
and
Amendment of Directive 76/769/EEC regarding restrictions on marketing and use of mercury
Renate PAUMANN
Austrian Federal Ministry for Agriculture, Forestry, Environment and Water Management
This presentation does not necessarily reflect the official opinion of the Austrian Federal Ministry for Agriculture, Forestry, Environment and Water Management

2. Content of the presentation
A - REACH (Overview and practical aspects)
B - Transitional measures regarding restrictions from directive 76/769/EEC to REACH
C - Restrictions on the marketing and use of certain measuring devices containing mercury (amendment of directive 76/769/EEC)

3. Why do we need REACH ?
Old Chemicals management system was inefficient:
Difficult to identify risks + difficult to address risks
Lack of information about most chemicals on the market (“existing” versus “new” chemicals)
Burden of proof on authorities
No efficient instrument to deal with problematic substances
Lack of incentives for innovation
Lack of confidence in chemicals
 REACH into force on 1 June 2007

4. In some figures, REACH is….
1: one single and coherent system for “existing” and “new” substances
40: existing EU legislative texts integrated into REACH
450: staff members in the European Chemicals Agency (ECHA) in 2010
1 500: substances currently identified as potentially eligible, for certain uses, to the authorisation procedure
~ : substances under the scope of registration procedure ( > existing substances)

5. Substances with high volumes and those of greatest concern!
REACH – key elements
Registration of substances ≥ 1 tonne/year
Increased information and communication throughout the supply chain
Evaluation of some substances
Authorisation only for substances of very high concern
Restrictions - the safety net (Community wide action)
Agency to efficiently manage system
Focus on priorities:
Substances with high volumes and those of greatest concern!

6. Registration (1)
What?
Registration only concerns substances (alone or in preparations and in certain cases in articles)
Limited information for intermediates and exemption for polymers
Transitional regime and pre-registration for “phase-in” substances
Chemical Safety Assessment (CSA) for > 10 tonnes
Principle of “joint submission” of data (for the same substance to be registered by different registrants)

7. Registration (2)
How ?
Manufacturer/Importer obtains/generates adequate information
Manufacturers of substances outside the EU may appoint an “only representative”
Data sharing obligatory for tests on vertebrates (on other tests voluntary)  by means of SIEFs *
Electronic dossier submitted to Agency
Certain non-confidential information to central (largely public) database
* Substance Information Exchange Fora

8. Registration : main deadlines
1 June 2007
EiF
Agency’s EiO
1 June 2008
Publication of pre-registered substances
1 January 2009
≥ 1t/y
31 May 2018
Pre-registration
1 June 2008 – 1 Dec. 2008
t/y
31 May 2013
≥1000 t/y
CMR ≥1 t/y
aqu.tox. ≥100 t/a
30 Nov. 2010
Preparation of test strategies
Registration for “new” substances
SIEF

9. Information exchange in the supply chain
The Safety Data Sheet (SDS)
Exposure scenarios based on Chemical Safety Assessment (CSA) annexed to SDS (if ≥ 10 t/y)
Information on substances of very high concern in articles (if ≥ 0.1%)
Specific obligations for Down-Stream-Users: have to apply risk control measures identified in the SDS / their CSAs, make a use know to the supplier, inform on new hazards, notify uses to agency under certain conditions

10. Evaluation (1) Dossier evaluation Substance evaluation
Two different types of evaluation:
Dossier evaluation
For all substances by ECHA
Substance evaluation
For selected substances by Member States (under the lead of ECHA)
Community rolling plan

11. Evaluation (2) Dossier evaluation:
Checking compliance of all registration dossiers (compliance check)
Checking of test proposals
Substance evaluation:
Review of information for selected substances
Mechanism to request further information from registrants
Information generated through evaluation:
 to be used by M/I to manage risks
 may trigger authorisation or restriction

12. Restriction (1) A “safety net” that can be initiated by:
a Member State, or
the European Commission
Scope:
substances / preparations / articles,
manufacturing, placing on the market and use

13. Restriction (2) When ? How?
If there is an unacceptable risk to human health or environment not yet tackled by registrant which has to be addressed on a community wide basis
 Committee decides on amendments of Annex XVII of REACH (restrictions)
 Decision shall take into account socio-economic impact and availability of alternatives

14. Authorisation (1) Substances of very high concern:
CMR substances (cat 1 and 2)
Carcinogenic, mutagenic and toxic for reproduction substances meeting the criteria for classification in category 1 and 2
PBT and vPvB substances
Persistent, bioaccumulative and toxic substances and very persistent and very bioaccumulative substances in accordance with criteria in Annex XIII
Substances of equivalent concern with scientific evidence of probable serious effects

15. Authorisation (2) Authorisation procedure:
Identification of substances for the candidate list (first recommendation for candidates by 1 June 2009)
Prioritisation of substances
Inclusion of substances on Annex XIV *
Application for authorisation
Granting/refusal of autorisation
Review of authorisation
* Contains substances identified as of very high concern and subjected to authorisation

16. Authorisation (3)
An authorisation for the use of a substance listed in Annex XIV will be granted only if:
the risks are adequately controlled, or
the risk are not adequately controlled, but it is shown that socio-economic benefits outweigh the risk to human health or the environment arising from the use of the substance and if there are no suitable alternative substances or technologies

17. Practical aspects of REACH implementation

18. European Chemicals Agency - ECHA
ECHA is established for the purpose of managing the technical, scientific and administrative aspects of the REACH Regulation
From 1 June 2008 the Agency will have the following main tasks:
Providing technical Guidance Documents and assistance to registrants
Managing registration applications
Performing dossier evaluations
Co-ordinating substance evaluations, authorisations and restrictions

19. Tools made available by the Commission/ECHA
Guidance documents (cf. RIPs) and the overall guidance package made available on ECHA’s website
IT tools (IUCLID 5 / REACH IT)
Conferences all over Europe and in some third countries

20. The overall guidance package
Objective:
Allows stakeholders to quickly understand REACH and their roles and obligations under REACH
As exhaustive as possible to cover the users´ needs
Web application: ECHA’s website as a “one stop shop” for all relevant information on REACH since 1 June 2007:

21. What does the guidance look like?

22. REACH Implementation Projects - RIPs
AIM: to develop in close collaboration with all stakeholders guidance helping to fulfil the obligations under REACH
RIP 1: REACH Process Description
RIP 2: REACH – IT
RIP 3: Technical Guidance and Tools for Industry
RIP 4: Technical Guidance and Tools for Authorities
RIP 5 & 6: Setting up the Agency
RIP 7: Preparation of the new tasks for the Commission
RIP 8: Agency Standard operational procedures

23. Member State helpdesks
Network of helpdesks
Agency
Network
Helpdesk exchange forum Correspondents network
Agency acting as focal point
Industry helpdesks
Industry helpdesks
Industry helpdesks
Committees (MSC, RAC, SEAC)
Committees (MSC, RAC, SEAC)
Committees (MSC, RAC, SEAC)
Support to helpdesks
Maintain knowledge database
Manage FAQ
Member State helpdesk
Member State helpdesk
Agency “helpdesk”
Member State helpdesks

24. Transitional measures on restrictions (from Directive 76/769/EEC to REACH)
Restrictions on the marketing and use of certain measuring devices containing mercury (amendment of directive 76/769/EEC)

25. Transitional measures on restrictions
Existing restrictions (76/769/EEC) are included in Annex XVII of REACH
Restrictions adopted under 76/769/EEC from 1 June 2007 shall be incorporated in Annex XVII by 1 June 2009
Restrictions in preparation under 76/769/EEC, which are already submitted to the relevant institutions, should be incorporated in Annex XVII by 1 June 2010 (based on proposal from Commission)
Directive 76/769/EEC will be repealed with effect from 1 June 2009

26. Restrictions on Mercury
It is estimated that 33 tons of mercury are used for measuring and control devices per year in the EU (from which tons in thermometers)
EU-Mercury Strategy 2005 therefore proposed to take action on this product group by means of directive 76/769/EEC (Action 7)
AIM: To protect environment and human health by reducing the amount of toxic mercury entering the waste stream

27. Restrictions on Mercury
Dir. 2007/51/EC amending dir. 76/769/EEC phases out marketing and use of mercury in
fever thermometers
other measuring devices (barometers, manometers, sphygmomanometers, etc. ) intended for being sold to the public
Two-years transitional period for barometers
Antique instruments will not be affected
Commission will review the availability of reliable safer alternatives to measuring devices in professional use

28. Thank you for your attention…