Huge list of chemicals for assessment in 2018 REACH round
Source: WTIN Date: 2014-03-11
The extent of the potential impact on the textile industry of the next stage of European Union (EU) chemical control system REACH – the registration of chemicals of small volumes (10 tonnes a year and above) – has been made clearer by the European Chemicals Agency (ECHA).
Experts considered this 2018 registration at a specialist briefing held at the ECHA HQ in Helsinki yesterday (March 6). Christel Musset, ECHA director of registration, said that the agency is expecting between 25,000 and 50,000 substances – many of which are used in the textile industry – to be registered prior to the 2018 deadline, and between 40,000 and 70,000 registration dossiers to be presented to ECHA.
Ms Musset said that ECHA had initially anticipated around 30,000 substances to be registered by 2018. The revised expected figures for 2018 compare with around 3,400 substances and 20,000 dossiers for the 2010 deadline (of chemicals used in annual volumes of 1,000 tonnes and more), and around 3,000 substances and 9,000 dossiers for the 2013 deadline for chemicals used in volumes of between 100 and 1,000 tonnes per year.
Ms Musset said that the 2018 deadline will have a particularly significant impact on small-and-medium-sized enterprises (SMEs), and will probably involve more SMEs due to it involving chemicals in smaller volumes. "We expect many more SMEs [to be registering for the 2018 deadline] than in 2013," she said, adding that currently around 20% of the companies that have registered substances under REACH so far are SMEs.
However, she also said that large chemical product suppliers will also be significantly affected by the 2018 deadline. "Many large companies we've been talking to have told us that, for them, the 2018 deadline is actually much bigger [than 2010 or 2013]." She said that because large companies have so many dossiers to submit that many will start to register their substances for the 2018 deadline in 2016.
Ms Musset added that another significant impact of the 2018 deadline is that many more companies and individuals will be involved in substance information-exchange forums (SIEFs), and also that ECHA is expecting far fewer dossiers per substance to be presented because many of the chemicals to be registered by 2018 are speciality chemicals.
She outlined a number of plans that ECHA is working on in order to help the large number of SMEs that will be involved with the 2018 deadline. She noted that there are numerous challenges for SMEs, including: the complexity of the legislation; working in English; the complexity of SIEFs, particularly cooperating with competing companies; Letter of Access costs (these grant permission for a registrant to use or refer to a single study or set of studies by a data owner); the cost and quality of consultants; and the power of large companies.
She said that ECHA is planning to simplify as much of the process as possible, including the IT tools, guidance, manuals, and the registration procedure itself. For example, it is aiming for as much of the registration process as possible to be intuitive for the user so that few if any manuals are actually required. She also said that particular attention will be paid to the SIEFs. She explained that it was important that companies that register jointly make sure they are talking about the same substance during a SIEF.
"When arriving at the evaluation stage there have been discussions post-registration between companies about whether or not they really have the same substance," said Ms Musset. "That's a process which is quite complicated for the companies and even for us also. So it would be good for the 2018 deadline for companies to look seriously at the substance identification and make sure they are taking about the same substance, so that they can use the same data for their registration dossier."
She added that ECHA is "looking at how we can communicate best practice in SIEFs.”We are working with the companies and industry representatives to see what exists already and how we can give advice in to the SIEFs."
She said that other plans to help SMEs include more multilingualism – although many of the SIEFs choose to conduct their work in English. "We are working with authorities and industries on the ENES platform – which is an exchange network – and how we can help the communication between suppliers and downstream users," she said.
Aside from the registration process, another aspect of REACH of particular concern for the textile industry is the authorisation process, which identifies problem chemicals for which companies must secure special permission to use. Addressing fears from the industry that certain chemicals that are currently used in textile manufacturing might have to be dropped, Augusto Di Bastiano, a senior scientific officer at ECHA, emphasised in an interview with WTiN that textile companies and industry associations have the opportunity to be fully engaged with the authorisation process.
"This process goes through many steps," he said. "There are public consultations about the substances, which means that everyone – industry associations, NGOs, companies and individual persons – can contribute comments on the proposals. All those comments are taken into account - and before a final decision is taken there is a discussion by committees that include representatives from member states, industry associations, and so on."
He added that it is important that textile manufacturers "are all watchful of the type of chemicals they use," and that if a chemical is listed for example as an substance of very high concern (SVHC), and hence a candidate for being placed on the REACH authorisation list, they should follow what the specific requirements are regarding REACH.
Jack de Bruijn, ECHA’s director of risk management, added that there has so far been a "relatively low" number of applications for authorisation. ECHA data shows that it has so far received 17 notifications to submit an application for authorisation. He said that this, along with the relatively low number of chemicals that are carcinogenic, mutagenic and toxic for reproduction (CMR) registered, suggests that "substitution to safer chemicals is actually happening," although he said that it is difficult to quantify for ECHA as "when an industry decides to substitute, especially at the downstream user level, ECHA does not necessarily get the information."
Meanwhile, the process of registering biocides under REACH looks set to accelerate. Hugues Kenigswald, head of the biocides assessment unit at ECHA, told WTiN that a number of new features introduced under the new Biocidal Product Regulation (BPR), which came into effect in September 2013, replacing the previous directive, "will contribute to an acceleration of the assessment of the biocidal active substances and the biocidal products before they can be used on the EU market."
He pointed to simplified and streamlined procedures for the approval of active substances and the authorisation of biocidal products, such as textiles treated with antibacterials, explaining that all biocides applications are now processed in a paperless form through an electronic submission system called R4BP 3 that companies use to submit their dossiers and authorities use to exchange information.
He stressed that applicants can participate in discussions held by the Biocidal Products Committee (BPC), which prepares the opinions of ECHA related to several BPR processes which feed into final decisions taken by the European Commission under the regulation.
