ECHA

ECHA Newsletter asked some of the Agency's accredited stakeholders their views on the outcome of the second REACH registration deadline.

 

Erwin Annys, European Chemical Industry Council, Cefic

The chemical industry has met the second registration deadline in time, as it did for the first. The second phase was in a certain way more difficult than the first registration deadline. In 2010, registration was the only issue. This time, companies have had to simultaneously handle the new registrations, the updates of previous registrations, as well as the results of dossier and substance evaluation, the development of the Candidate List and, in some cases, even the first applications for authorisation. The total impact of REACH on companies becomes more and more clear.

Until now, the number of small and medium-sized enterprises registering has been rather limited, as expected. For the next deadline, however, we expect SMEs to register many more substances, and in many cases they may be the only company registering the substance, placing the full responsibility very much on their own shoulders. The number of substances to be registered is also expected to be seriously higher than the combined number of substances for 2010 and 2013. Despite the fact that the information requirements are less, the total workload will seemingly be much higher and will be done by less experienced companies.

The European Commission in their review, ECHA in their communications and industry associations are all stressing on the need to help SMEs for 2018. As the chemical industry, we believe that a close collaboration on how to get the required information with less burden for companies will be beneficial not only for SMEs but for all companies confronted with the REACH obligations.

Cefic

 

Eurometaux

 

Sylvie Lemoine, international Association for Soaps, Detergents and Maintenance Products, A.I.S.E

We hope this second phase of REACH is a success, despite the recent concerns expressed by ECHA in relation to delays in substances due to be registered in 2013 actually being registered on time. So far, in our membership, we have not heard of essential chemicals that have not been registered.

We remain concerned with the quality of data communicated in the supply chain and the ability of downstream users to meet their legal duties. In this respect, we hope that the coverage of uses and the quality of extended safety data sheets will improve after the lessons learnt from 2010, although we acknowledge a lot remains to be done in terms of standardisation and harmonisation of exposure scenarios.

We are also increasingly concerned about the impact of substance evaluation decisions on downstream users, in particular when they have not been contacted in the evaluation process. In some cases, downstream users may have useful information to provide (e.g. risk information) to avoid decisions being based on limited and unrealistic criteria or assumptions. 

In general, we share the concerns of other parties regarding the complexity and heavy burden for SMEs, at all levels.

We hope that ECHA will, in the coming years, continue to provide active support to downstream users to help them fulfil their duties, create smoother work processes, and implement the new biocides regulation effectively and in full transparency.

A.I.S.E

 

Uta Jensen-Korte, European Association of Chemical Distributors, Fecc

Fecc have received a number of enquiries both prior to and following the May 2013 registration deadline that indicates the preparation to meet the obligations was extremely difficult. While we know that our members were busy with the preparation of dossiers as well as their other REACH obligations (2010 dossiers update, authorisation, evaluation) they were often hampered by forces outside their control.

There were a number of examples of lead registrants registering very close to or on 31 May, which resulted in severe anxiety within the substance information exchange forums (SIEFs). Some joint registrants had to register after the deadline because the lead registrant would not release their token until they had received confirmation of their registration.

Some non-EU companies announced very late that they were not going to register, which caused difficulties especially as, in some cases, stock was already on the sea travelling to Europe and was due to land after the deadline.

A number of consortia within SIEFs were requesting unreasonable fees for letters of access very close to the deadline. They had no chance to look for alternative options and either had to pay or withdraw.

After the 2010 registration deadline, there was a constant stream of IUCLID and guidance updates. In itself each change may not have caused a specific issue, but it slowed down the whole process for 2013. With regard to IUCLID, the lead registrants from 2010 had to update their dossiers after the July 2012 update before they could issue anything to anyone. This slowed the whole process down and meant that a number of organisations were delayed in starting registrations for 2013 because the lead registrant was ‘playing it safe' and not doing a lot of work until the amendments had stopped.

The same concern was raised regarding guidance.  For instance, after the 2010 deadline there were issues for UVCB* substances regarding a few registration dossiers, raised by ECHA. This caused issues, lemon oil being one, where the whole registration process had to be reformatted even though the guidance was still ambiguous.

Even though a prohibition on amending guidance six months before any deadline is always in place following the 2010 experiences, this still meant that a number of guidance documents were changed in 2011 and 2012, meaning that SIEFs had to review their work to ensure that it met all the new guidance, which caused an extra amount of work and further delays.

All of these issues above meant that a number of Fecc members, who were fully resourced and ready to go, could not actually do anything whilst the SIEF and the lead registrants were ensuring that their dossiers would work in the system. This resulted in a number of sleepless nights worrying whether they were going to be able to be compliant with the regulations.  

To illustrate the level of resource necessary to comply, one company (that we are aware of) had two members of staff working their contracted 140 hour month to handle a number of lead and joint registration dossiers. They both also had to work an additional 100 hours overtime for 3.5 months (January to April) to meet the deadline. They could not find any ‘top up' experienced resources available to help them cope with the peak demand of the 2013 deadline.

It is important that industry now focuses on the 2018 deadline which will be a real challenge in terms of number and size of companies involved – mostly SMEs, as the deadline requires the registration of substances produced or imported in lower volumes. This will mean that data generation and data access costs will become a major issue which could lead to potential disruption in the supply chain.

In the coming years, ECHA and industry need to work together to develop supportive mechanisms and simpler (IT) tools for SMEs to register their substances.

Not only does the administrative burden need to be reduced, but simplifications and the overall costs of registration for low volume substances need to be considered.

Raising awareness among the smaller companies to remind them about their duties will be a challenge, especially reaching those which are not members of any trade association.

* Unknown or Variable compositions, Complex reaction products and Biological materials

Fecc