REACH Registration and enforcement
Latest trends in REACH
and CLPTokyo 30 March 2010
Laura Walin
ECHA – Guidance and helpdesk

REACH and ECHAØ REACH Regulation entered into force 1 June 2007

Ø ECHA was created in this regulation
Ø ECHA became operational 1 June 2008
Ø Building up phase till 2010
q Number of staff now ~ 380 will grow by the end of 2010 to ~ 490

Ø ECHA is managing the implementation of the REACH

Regulation 1907/2006
Ø ECHA is not a policy maker

http://echa.europa.eu

2ECHA – the coordinator of
REACH implementation
MISSIONORGANISATIONØManage REACH and CLP tasksØEnsure a consistent implementation at
EU/EEA level

Ø

Ø

Ø

Ø

Ø

Provide with the best possible
scientific advice on safety and socioeconomic aspects of the use ofchemicals
Ensuring a credible decision-making
process, using the best possible
scientific, technical and regulatory
capacitiesØ Management BoardØ Executive Director

Ø Secretariat (currently staff of 350)

Ø Three Scientific Committees

ØForum on Enforcement

Manage guidance, IT tools and data
bases

Ø

Networks (Help Net, RCN, SON)

Support national helpdesks andprovide advice to registrantsØ

Board of Appeal

Make info on chemicals publicly
accessible
http://echa.europa.eu

3

REACH: Main featuresØNew registration requirements for old substances.

Ø

Data sharing as a general principle.

ØIndustry to generate information about substances andadopt risk management measures.

Ø

Increased obligations to transmit information down the
supply chain.

ØNew authorisation procedure.

http://echa.europa.eu

4

REACH – Registration
Current status

http://echa.europa.eu

5Registration ofphase-in substancesFirst deadline 30 November 2010ØSubstances ≥ 1000 tonnes per yearØCMR category 1 and 2 substances≥ 1 tonne per yearØVery toxic to the aquatic environment (R50/53) ≥ 100
tonnes per year
Need to have pre-registered the substance to benefit
from extended registration deadline(s)http://echa.europa.eu

6

REACH: Registration in practise

Create theDossier in
IUCLID 5

Submit theDossier in
REACH-IT
INDUSTRY

Business
Rules

TCC and
Invoicing

Pass/Fail
Decision

ECHA

http://echa.europa.eu

7

Business rules
Business rules are a set of pre-requisites that must be fulfilled before REACH-IT
can establish that the dossier can be handled properly and that the required
regulatory processes can be successfully carried out.

Three main reasons for failure:• Format - e.g. wrong IUCLID 5 template• Administrative - e.g. registration update does not provide a valid
reference number• Technical – REACH-IT cannot ‘understand’ the substance identifiers

http://echa.europa.eu
http://echa.europa.eu

8

Business rules

Further information:• Data Submission Manual 8: Business Rules validation– Provides list of all business rules and how to avoid failures• Forthcoming webinar on business rules on 22 April 2010

http://echa.europa.eu

9Technical Completeness Check• The minimum information required in a dossier isdependant on the tonnage band covered by theregistration.
• In case the registration is incomplete (TCC fails),
ECHA sends a request for further information and setsa deadline to resubmit a complete dossier.

http://echa.europa.eu
http://echa.europa.eu

10Dossier processing at ECHA
Check of Business Rules(ensure that dossiers can be processed by the system)

Invoice (if needed)
Completeness check:
Technical CompletenessCheck (TCC)+

Check if payment wasreceived in full

(Request to complete dossier, if needed+ 2nd Completeness Check)
pass

fail

Registration number

Rejection

http://echa.europa.eu

11Registration Dossiers

Data from 01/06/2008 till 22/02/2010

http://echa.europa.eu

12Registrations by tonnage

Data from 01/06/2008 till 22/02/2010
Note: registration dossiers that combine a registration for e.g. an on-site isolated intermediate (OSII) and/or transported isolated intermediates(TOSII) were counted as separate registrations, data is indicative.

http://echa.europa.eu

13Registration dossiers –accepted for processing% failed BRv by ‘Submitted registrations’ and ‘Month’ (till 22/02/2010)

Note: the % failed in BRv is calculated from the number of submitted dossiers, data is reported by submission date, data is indicative.

http://echa.europa.eu

14Registration dossiers
Registration dossiers received by Phase-in and Month (till 24/02/2010)

Note: numbers are derived from registration dossiers accepted for processing (after BRv).

http://echa.europa.eu

15Registration dossiers and TCC% failed TCC by ‘Registrations accepted for processing’ and ‘Month’ (till 22/02/2010)

Note: the % failed in TCC is calculated from the number of dossiers accepted for processing, data is reported by submission date, data is
indicative.
http://echa.europa.eu

16

Evaluation - Compliance Check

Ø Aim
q Verify compliance with information requirements

q Check adequate justifications for adaptations

Ø Which dossiers
q Only selected dossiers (Article 41)

q At least 5% of dossiers from each tonnage band

http://echa.europa.eu
http://echa.europa.eu

17Key messages Recommendations/1
Evaluation Report 2009 published 1 March 2010
The identity of the registered substance and thesubstance used for testing were not clearly described(precise composition and impurities)
Providesufficient information on substance identity
Ø Testing was omitted based on inappropriate or poorly
justified scientific arguments
Provide adequate
justification for QSAR, Read across, grouping and weightof evidence casesØ

http://echa.europa.eu
http://echa.europa.eu

18Key Messages recommendations/2
Evaluation Report 2009 published 1 March 2010
The summaries of test reports did not include enoughdetailed information
Ensure good quality for robust
study summaries
Ø Shortcomings related to the risk assessment and therecommended risk management measures
Check
the exposure scenarios and CSR for consistency andcompletenessØ Omission of the classification and labelling information
specified by the CLP Regulation.
Ø

http://echa.europa.eu
http://echa.europa.eu

19

REACH – Disseminationof information

http://echa.europa.eu

20Dissemination of informationØ

According to REACH legislation, ECHA will provide
public access to (non-confidential) information onregistered substancesq Accessible and useful also to countries outside the EUØEven publicly available information will be highly
technicalØ

A dissemination website is being developed for 2010

Ø

Other ECHA initiative: hosting the OECD Global Portal
http://echa.europa.eu

21Dissemination of informationØØØ

ECHA shall provide free public access to information on registeredsubstancesA ‘dissemination’ website is being produced for 2010 which will
include (non-confidential) information
q from registration dossiers
q on notified substancesq collected under previous
legislationq other REACH processes
q C&L data
Other ECHA initiative:
future hosting OECD Global
Portalhttp://echa.europa.eu

22How are dossiers processedØIT-application for dissemination of information fromregistration dossiers is developed in-house

FilterØ

Aggregate &track updates

Publish129 substances, registered before 01.10.2009, listed in
EINECS or dangerous without a confidentiality claim on
the substance name published on 18 December 2009http://echa.europa.eu

23

Tips for registrants
Discuss dissemination in the SIEF
Ø Do not include confidential information (e.g. company
name) in public fields (e.g. guidance on safe use)
Ø Avoid referring to attachments in public fields (e.g. in
guidance on safe use)Ø Carefully review your dossier before submission: ECHA
cannot make changes to the filtered dossier; resubmission
is needed if you have concerns about publication
Ø The manual for dissemination (Q1 2010) and the IUCLID
plug-in for dissemination (Q2 2010) will be available soonØ

http://echa.europa.eu

24

REACH – Review of Annex II

http://echa.europa.eu

25

Review of Annex IIof REACH
Draft by the Euroepan Commission
Ø Positive vote in the REACH Committee 9 Dec 2009
Ø Scrutiny of the European Parliament and the Council
until 13 Apr 2010Ø If no opposition, swift adoption by the CommissionØ

http://echa.europa.eu

26

Review of Annex IIof REACH
Ø

Proposed section 1.1 of Annex IIØ Part of registration number referring to individual registrant may beomitted by distributor or a downstream user if this supplierØ assumes the responsibility to provide the full registration number
upon request for enforcement purposes, or if not available to him,
to forward the request to his supplierandØ provides the full registration number to the enforcement authority
within seven days (upon request of this authority or forwarded byhis recipient), or, if not known to him, shall forward the request to
his supplier and at the same time inform the enforcement authority
thereofhttp://echa.europa.eu

27

REACH – ECHA support
for registrants

http://echa.europa.eu

28

From pre-registration
to pre-SIEF
Ø At the end of pre-registration
q 2 750 000 pre-registrations
q 65 000 companies
q 146 000 substances pre-registeredØ The list of substancesq Published 19 December 2008, updated 27 March 2009
q Information from data holders

Ø Starting from a pre-SIEF
q REACH-IT brings companies that pre-registered the “same”
substance together in a “pre-SIEF” webpage
q You can see contact details of other pre-registrants and dataholders
q You can start to look for “similar to” substances
http://echa.europa.eu

29Forming SIEFs – a challenge
Crucial to the success of REACH
Ø Essential if we are to minimise unnecessary testing andcosts to industry
Ø Getting started is a challenge and is urgent
Ø ECHA is doing what we can but industry to lead
Ø New awareness campaign “the clock is ticking… form
your SIEF now”
Ø Dedicated web section for support
http://echa.europa.eu/sief_en.asp
q Getting Started in SIEFs – Top Tips
q SIEF – key principles.
q ….
Ø

http://echa.europa.eu

30

SIEF Awareness Campaign•

Aims– SIEFs formed and Lead Registrants nominated– Early submission from Lead Registrants of high quality dossiers– Submission of all dossiers before the deadline– Removing the barriers• Developing clearer lines and recommendations• Translations– Raising awareness of the urgency ”The clock is ticking”• Trade associations and Helpdesks• Emails to all pre-registrants– Supporting Lead Registrants- Lead Registrants’ Workshop on 11Sep09
http://webcast.ec.europa.eu/dgenttv/portal/_vi_fl_300_en/index.html?viewConference=7497• Lead Registrant Forum (http://lr.echa.europa.eu)• Monthly webinars (http://www.echa.europa.eu/news/webinars_en.asp)• Special Helpdesk support

http://echa.europa.eu

31

Weekly update of SIEF Formation
Approx 10% of the total number are candidate lead registrants
Date

SIEF in progress

SIEF in progress
Apr-0957

May-09293

Jun-09574

Jul-09982

Aug-091327

Sep-091766

Oct-091928

Nov-092051

Dec-092195

Jan-102282

03/02/10

2306

17/02/10

2374

2500

2000

1500

1000

500

0

9
9
9
9
9
9
9
9
0
0
9
00
00
00
00
00
01
01
00
00
00
00
2
2
2
2
2
2
2
2
2
2
2
/
/
/
/
/
/
/
/
/
/
/
/11
/01
/04
/10
/12
/02
/05
/06
/07
/08
/09
01
01
01
01
01
01
01
01
01
01
01

http://echa.europa.eu

32

Lead Registrant status(17Feb10)• 2352 SIEFs active or in progress• Approx. 650 legal entities informed ECHA
• 1932 substances indicated for the 2010 registration
deadline– 177 for 2013
– 160 for 2018
– 45 substances still no deadline

http://echa.europa.eu

33

Lead Registrant Support•

Monthly webinars (http://www.echa.europa.eu/news/webinars_en.asp)– Targeted to help the LR; clarifications / technical issues– From Nov 2009 until Apr 2010
– Available online to all afterwards•

Special helpdesk support– Focus on LRs (National HD will support others)– No individual service, but response to collective concern– Provide time-limited phone service (outbound only) close to the deadline•

Facilitation of communication within SIEF
– New process to put in place soon to facilitate contacts between REACH
actors and lead registrants in LR database•

Further Support– Analysis of the intentions to register by 2010 deadline and of SIEF progress– Inventory of issues compiled by industry: replies/ proposals prepared tofacilitate prioritisation

http://echa.europa.eu

34

SIEF / LR Conclusions• ECHA committed to provide support to industry• Communication is key both within SIEFs and towards
ECHA• Companies are making progress• Companies may learn from each other (Forum, Trade
associations)• Need to know Lead Registrants for Special support• Further activities to support LR progress and success of
SIEFs• Recently: Directors Contact Group (IND, COM, ECHA)
http://echa.europa.eu

35

OVERVIEW OF WEBINARS IN 2009

WEBINAR

DATE

General Principles of Dossier
Preparation and Submission
Information Requirements I
Information Requirements II

4 November
30 November
10 December
25 January

Substance Identity
http://echa.europa.eu

36

WEBINAR PLAN 2010
WEBINAR

DATE

Technical Completeness Check Tool
(TCC)

25 February

Chemical Safety Report (CSR) and CSA– part I

09 March

Chemical Safety Report (CSR) and CSA– part II

26 March

Classification and Labelling

09 AprilBusiness rules

22 March

Data sharing

30 April

http://echa.europa.eu

37

REACH - Enforcement

http://echa.europa.eu

38

EnforcementØEnforcement and penalties are the responsibility of theMember States (Article 125 and 126 of REACH)

Ø

Member States are obliged to establish the necessary
arrangements for the implementation of REACHØ

Some legal instrument is required at national level

http://echa.europa.eu

39

The Forum for Information
Exchange on EnforcementØ

Coordinates a network of Member States' competentauthorities responsible for enforcement

ØTasks include:
q Promotion of best practices & tools (Minimum criteria forinspections adopted)
q Development of electronic info exchange proceduresq Identification of enforcement strategies

q Coordination and evaluation of harmonised enforcement projects
q Liaison with industry
q Advising on enforceability of restriction proposals

http://echa.europa.eu

40

Establishment of FORUM
Members– One per Member State– 3-year term, renewable– Contact with MS and CAs• Broad range of relevant expertise• FORUM members are independent

http://echa.europa.eu

41

FORUM Working Methods• Decisions and Conclusions– Plenary meetings 2-3 times each year
– Written procedures• Work Programme• Working Groups– Specific in-depth discussions chaired by one Forum member;composed of Forum members and invited experts– Documents as basis for discussions of the Forum, to prepare
conclusions, statements, positions

http://echa.europa.eu

42Working Groups - finalised
•
•
•
•
•

Forum Work Programme
Advice on enforceability of revised Annex XVIIEnforcement strategies, best practice
Report to the Commission under Article 117
Minimum criteria for inspections– Ensuring a level playing field within the Internal Market
and better coordination of REACH enforcement within
EU/EEA

http://echa.europa.eu

43Forum Current WorkØ

1st Enforcement Project (REACH-EN-FORCE 1)
q Pre-registration, registration & SDS
q 26 countries participate >1000 inspections
q Report will be ready in Q3 2010 at the latest

ØPreparation of Forum enforcement project for 2010
q Another major enforcement project will focus on formulators of

mixtures and their Downstream User obligations

http://echa.europa.eu

44Forum Current WorkØ

Cooperation with custom authorities
q Draft recommendation to customs on how customs can be

involved in control of REACH (imports)
q Preparing recommendation for procedure for control of Article
5 by customs and REACH enforcers
q Customs and REACH enforcers will work together to stop
un-registered substances from being released for freecirculation
q Once recommendations are finalised, Forum will approachMember State customs authorities via DG Taxation andCustoms Union

http://echa.europa.eu

45Practical enforcement?
• Limits of coordination…
– Enforcement Structures in Member States• Possibilities for coordination…
– Enforcement approaches• Key to ensure same situation on the market– Strategies• Practical experiences from enforcement discussed
at every meeting
http://echa.europa.eu

46

FORUM Conclusions• Important to have coordinated enforcement• Successful in coordinating enforcement in 30 EU/EEA
states• Ensures an equal treatment of companies throughout the
EU/EEA• Composition is stable• Atmosphere is constructive, active contributions• Members discuss practical issues and aim towards
achievable solutions

http://echa.europa.eu

47

To conclude

http://echa.europa.eu

48

ECHA – REACH Achievements
ØFirst candidate list published 28 Oct 2008
q 15 substances – Information obligations

ØPre-registration closed 1 December 2008
q 2,750,000 pre-registrations received

q 146,000 different substances pre-registered

SIEF awareness campaign launched in May 2009
Ø First recommendation for authorisation sent to COM 1
June 2009 - 7 substancesØ Second candidate list published 13 Jan 2010
Ø Lead registrants activities launchedØ

http://echa.europa.eu

49

Main challenges for 2010
Ø Handling submitted registration dossiers - first

REACH deadline 30 November 2010
Ø Handling hundreds of test proposals andcompliance checks within legal deadlines
Ø Upgrading REACH-IT and IUCLID 5

Ø Providing guidance and help to registrants

http://echa.europa.eu

50

Welcome to Helsinki
4th ECHA Stakeholders’ Day

http://echa.europa.eu

51

Do not miss….
Stakeholders’ Day 19 May 2010 (just ahead of HCF)
Ø IT Tools for Industry (including CHESAR)Ø C&L notification and campaign
Ø Lead registrants can meet ECHA dossier handlers

Ø Dissemination of information from registration dossier

http://echa.europa.eu

52Helsinki Chemicals Forum
20-21 May 2010 - Programme
1. Opening comments
–
–
–

2.
3.
4.
5.

Antonio Tajani, Vice President, European Commission - invited
Jussi Pajunen, Mayor of Helsinki
Geert Dancet, Executive Director, ECHA

Chemicals Regulation –Global Challenges
Chemical Policies – Emerging Economies
Competitiveness – Financial Constraints
Green Chemistry – Solution Provider
Keynote speakers:
President Martti Ahtisaari, the 2008 Winner of the Nobel Peace Prize, andProfessor Paul J Crutzen, the 1995 Winner of the Nobel Prize for Chemistry
http://finnexpo.multiedition.fi/wwwcem/cem/index.php
http://echa.europa.eu

53ECHA website
For any information about REACH, CLP and ECHA

http://echa.europa.eu

Follow the news
on our home page
http://echa.europa.eu

54

Thank you for your attention!

These slides represent the opinionof the author and do not
http://echa.europa.eu
constitute the official position of ECHA

55