Work
10.September 2009 - 00:00
Pre-registration under REACH
At the first stage of pre-registration under REACH, there were estimated to be some 1 500 to 3 000 substances in the over-1 000 ton category. Now, however, there are some 25 000 substances. Because of the number of relevant substances, the regulation's tight deadline for first-stage registration (1.12.2010) is extremely challenging both for manufacturers and for importers into the EU. Businesses have very little time left to learn about the procedures of the Substance Information Exchange Forum (SIEF) and agree on common rules. Does the Commission consider it possible that SIEF groups with fewer than 100 members can reach agreement on the substances to be registered during the first stage (those exceeding 1 000 tons)?
The largest pre-SIEF groups have more than 5 000 members.
Does the Commission remain confident that those SIEF groups which have thousands of members can reach agreement on the rules to be applied? How will the Commission prevent REACH in practice from becoming a goldmine for lawyers because of all the agreements required for SIEF?
Will the European Chemicals Agency ECHA manage to check the registration of the 25 000 substances involved at the first stage quickly enough to allow those businesses which join in later (join submission) unquestionably to do their part by 1 December 2010?
The classification of each substance has to be notified for inclusion in the classification, labelling and packaging (CLP) inventory by 1 December 2010 (manufacturer/importer, downstream user). It has been estimated that between 2 and 25 million such notifications will be submitted. The notifications are to be made electronically using a program which is not yet available. Does the Commission consider this procedure to be justified, bearing in mind that the aim is to have only one classification per substance in the inventory?
10 September 2009
Answer given by Mr Dimas on behalf of the Commission
The Commission is aware of the challenge for companies to form SIEFs and make them workable within the tight deadlines provided by REACH. The REACH Regulation(1) provides for setting up SIEFs and specifies general rights and obligations of the participants.
However, the internal operation of SIEFs lies within the competence of the SIEF members and REACH does not give a role to the Commission and ECHA to intervene in the operation of SIEFs.
However, the Commission, together with ECHA, has already taken several important steps in order to raise awareness among the potential registrants, inform SIEF members about their rights and obligations, prevent possible misuse and allow them to work smoothly within SIEFs. This includes meetings with industry representatives, information campaigns, clarifications provided through the helpdesk, the website and newsletters. Furthermore, ECHA, in collaboration with the Commission, issued guidance on data sharing. The most recent initiative is a workshop for the lead registrants to take place in Brussels in September 2009.
This all makes the Commission confident that despite a high number of SIEF participants, companies can fulfil their data sharing obligations under REACH. As a reaction to the high number of substances which have been marked for registration by 2010, ECHA has also made a re-assessment of the estimates and has found that the number of substances to be registered is much more likely to be close to the original Commission estimate of 9 000 substances, as some companies, in particular consultants, have systematically indicated their intention to register by 2010, despite the fact that they are very unlikely to do so. Also, even for the substances which are likely to be registered by 2010, a large number of pre-registrants is unlikely to register by that date.
Concerning the practicality of the SIEF operation, the Commission and ECHA have advised stakeholders involved in the operation of SIEFs to start their work despite the fact that many pre-registrants seem to be inactive and not responding to correspondence, while periodically keeping all SIEF participants informed about the progress of the work, in order to ensure transparency to all SIEF participants. It is up to all SIEF participants to assess and ensure the appropriate level of their involvement in the practical operation of the SIEF, including the question whether they wish to have recourse to the services of consultants.
The REACH Regulation provides strict deadlines for ECHA to undertake completeness checks of each registration submitted. ECHA will make every effort to ensure the respect of these deadlines. In particular, ECHA is testing REACH IT to manage up to ten times the number of registrations originally foreseen, a number which is very unlikely to occur. The Commission and ECHA have also recently clarified their interpretation on the rules applying to completeness check for the lead registrant and subsequent registrants in a joint submission. This also clarified that, according to the Commission’s and ECHA’s interpretation, subsequent registrants are not obliged to wait for the outcome of the completeness check of the lead registrant's submission before they can submit their dossier. Nevertheless, for practical reasons and to give full legal security, the Commission and ECHA have recommended to lead registrants to submit their registration dossier by 30 September 2010, to allow sufficient time for the subsequent registrants to submit their dossier by 30 November 2010.
With regard to the notifications of substances to be included in the CLP inventory, the Honourable Member should note that according to Article 40(1) of the recently adopted CLP Regulation(2), ECHA shall specify and make available the formats for submission of information pursuant to the obligation to notify substances to the classification and labelling inventory. Already during the final stages of adoption of the regulation, ECHA has started its preparations to provide industry with the appropriate Information Technology tools in due time for the deadline for notification. The Commission is providing support to ECHA in this respect within its competence.
(1) Regulation (EC) No 1907/2006 of Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC, OJ L 396, 30.12.2006.
(2) Regulation (EC) No 1272/2008 of Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (Text with EEA relevance), OJ L 353, 31.12.2008.
At the first stage of pre-registration under REACH, there were estimated to be some 1 500 to 3 000 substances in the over-1 000 ton category. Now, however, there are some 25 000 substances. Because of the number of relevant substances, the regulation's tight deadline for first-stage registration (1.12.2010) is extremely challenging both for manufacturers and for importers into the EU. Businesses have very little time left to learn about the procedures of the Substance Information Exchange Forum (SIEF) and agree on common rules. Does the Commission consider it possible that SIEF groups with fewer than 100 members can reach agreement on the substances to be registered during the first stage (those exceeding 1 000 tons)?
The largest pre-SIEF groups have more than 5 000 members.
Does the Commission remain confident that those SIEF groups which have thousands of members can reach agreement on the rules to be applied? How will the Commission prevent REACH in practice from becoming a goldmine for lawyers because of all the agreements required for SIEF?
Will the European Chemicals Agency ECHA manage to check the registration of the 25 000 substances involved at the first stage quickly enough to allow those businesses which join in later (join submission) unquestionably to do their part by 1 December 2010?
The classification of each substance has to be notified for inclusion in the classification, labelling and packaging (CLP) inventory by 1 December 2010 (manufacturer/importer, downstream user). It has been estimated that between 2 and 25 million such notifications will be submitted. The notifications are to be made electronically using a program which is not yet available. Does the Commission consider this procedure to be justified, bearing in mind that the aim is to have only one classification per substance in the inventory?
10 September 2009
Answer given by Mr Dimas on behalf of the Commission
The Commission is aware of the challenge for companies to form SIEFs and make them workable within the tight deadlines provided by REACH. The REACH Regulation(1) provides for setting up SIEFs and specifies general rights and obligations of the participants.
However, the internal operation of SIEFs lies within the competence of the SIEF members and REACH does not give a role to the Commission and ECHA to intervene in the operation of SIEFs.
However, the Commission, together with ECHA, has already taken several important steps in order to raise awareness among the potential registrants, inform SIEF members about their rights and obligations, prevent possible misuse and allow them to work smoothly within SIEFs. This includes meetings with industry representatives, information campaigns, clarifications provided through the helpdesk, the website and newsletters. Furthermore, ECHA, in collaboration with the Commission, issued guidance on data sharing. The most recent initiative is a workshop for the lead registrants to take place in Brussels in September 2009.
This all makes the Commission confident that despite a high number of SIEF participants, companies can fulfil their data sharing obligations under REACH. As a reaction to the high number of substances which have been marked for registration by 2010, ECHA has also made a re-assessment of the estimates and has found that the number of substances to be registered is much more likely to be close to the original Commission estimate of 9 000 substances, as some companies, in particular consultants, have systematically indicated their intention to register by 2010, despite the fact that they are very unlikely to do so. Also, even for the substances which are likely to be registered by 2010, a large number of pre-registrants is unlikely to register by that date.
Concerning the practicality of the SIEF operation, the Commission and ECHA have advised stakeholders involved in the operation of SIEFs to start their work despite the fact that many pre-registrants seem to be inactive and not responding to correspondence, while periodically keeping all SIEF participants informed about the progress of the work, in order to ensure transparency to all SIEF participants. It is up to all SIEF participants to assess and ensure the appropriate level of their involvement in the practical operation of the SIEF, including the question whether they wish to have recourse to the services of consultants.
The REACH Regulation provides strict deadlines for ECHA to undertake completeness checks of each registration submitted. ECHA will make every effort to ensure the respect of these deadlines. In particular, ECHA is testing REACH IT to manage up to ten times the number of registrations originally foreseen, a number which is very unlikely to occur. The Commission and ECHA have also recently clarified their interpretation on the rules applying to completeness check for the lead registrant and subsequent registrants in a joint submission. This also clarified that, according to the Commission’s and ECHA’s interpretation, subsequent registrants are not obliged to wait for the outcome of the completeness check of the lead registrant's submission before they can submit their dossier. Nevertheless, for practical reasons and to give full legal security, the Commission and ECHA have recommended to lead registrants to submit their registration dossier by 30 September 2010, to allow sufficient time for the subsequent registrants to submit their dossier by 30 November 2010.
With regard to the notifications of substances to be included in the CLP inventory, the Honourable Member should note that according to Article 40(1) of the recently adopted CLP Regulation(2), ECHA shall specify and make available the formats for submission of information pursuant to the obligation to notify substances to the classification and labelling inventory. Already during the final stages of adoption of the regulation, ECHA has started its preparations to provide industry with the appropriate Information Technology tools in due time for the deadline for notification. The Commission is providing support to ECHA in this respect within its competence.
(1) Regulation (EC) No 1907/2006 of Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC, OJ L 396, 30.12.2006.
(2) Regulation (EC) No 1272/2008 of Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (Text with EEA relevance), OJ L 353, 31.12.2008.