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2nd june 09
Seven Substances Of Very High Concern For Authorisation
The European Chemicals Agency (ECHA) recommends that seven chemical substances of very high concern (SVHC) should not be used without specific authorisation. Three of the recommended substances are classified as toxic to reproduction, one as carcinogenic and three fulfil the criteria for being persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB). They are all used in products to which consumers and workers are exposed.
The authorisation process seeks to ensure that the risks from substances of very high concern are properly controlled and that the substances are progressively replaced. From its list of 15 candidate substances ECHA prioritised the seven substances based on their hazardous properties, the volumes used and the likelihood of exposure to humans or the environment.
The seven substances are:
- 1. Musk xylene (vPvB)-A fragrance enhancer which is used for example in detergents, fabric softeners and fabric conditioners.
- 2. 4,4`-diaminodiphenylmethane.-MDA (carcinogenic). A hardener which is used for example in epoxy resins and adhesives.
- 3. Short chained chlorinated paraffins - SCCPs (PBT and vPvB). A substance mostly used as flame retardant and/or plasticiser in various applications such as high performance rubber, sealants, paints or textile coating.
- 4. Hexabromocyclododecane - HBCDD (PBT). A flame retardant which is used for example in polystyrene, which is then further processed for the production of insulation panels/boards or packaging products, and in textile applications.
- 5. Bis(2-ethylhexyl)phthalate - DEHP (Toxic for reproduction). A plasticiser which is used in a wide range of PVC and other polymers applications, such as for example flooring, roofing, coated fabrics, medical devices or primary packaging of medicinal products, as well as in various preparations such as for example sealants, adhesives and inks.
- 6. Benzylbutylphthalate - BBP (Toxic for reproduction). A plasticiser which is used for example in polymer products, and in particular in PVC for flooring applications, in textile and leather coating, as well as in various other preparations such as sealants, coating and inks or adhesives.
- 7. Dibutylphthalate - DBP (Toxic for reproduction). A specialist plasticiser which is used in particular in various polymer (PVC/non-PVC) applications (such as floor covering or primary packaging of medicinal products), and as a component of various preparations such as adhesives or paints.
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6th June 09
CEFIC publishes model REACH SIEF agreement.
Set of bilateral agreements is most efficient way to organise SIEFs for data sharing, corporate lawyers conclude
A model legal agreement that can be used by leaders of REACH substance information exchange fora (SIEFs) as a basis for organising data sharing has been made freely available today by the European Chemical Industry Council (CEFIC) in a bid to accelerate SIEF progress.
The agreement is the result of brainstorming by CEFIC's own legal experts and those of its member companies. It is intended to be used in parallel with REACH consortia agreements. Where consortia exist, it is assumed that these will constitute the SIEF leadership team. However, CEFIC has also published what it describes as a 'consortia-light' cooperative agreement that can be used to organise a SIEF leadership team in the absence of a consortium and where the SIEF has relatively few members.
Presenting the agreement at a CEFIC workshop in Brussels today, Anja von Hahn said in her experience, discussions in consortia with more than 20 members were difficult to manage. It can take five to six months for some groups to concur on a legal agreement and then some time before this is signed by all parties. In SIEFs with a large number of members, such a process would be impractical, even if there was not pressure to get data-sharing processes up and running urgently if they have to meet the 30 November 2010 registration deadline.
CEFIC's SIEF agreement takes the form of aggregated bilateral agreements with each SIEF member that the leadership team collectively undertakes on behalf of the SIEF. The lead registrant could be empowered to sign each agreement to minimise administrative burden.
The agreement specifies:
- The rights and obligations of the lead registrant
- Obligations of other SIEF members including rules on financial compensation
- Rules on ownership of information
- A statement of SIEF duration
- Rules on legal entity change
CEFIC proposes that SIEF leadership teams obtain proof that all SIEF members accept the agreement in one of three ways, of which it recommends the first two as being most efficient:
- By integrating a “tick box” option into their SIEF IT communication platforms, allowing companies to read the agreement and indicate that they subscribe to it.
- By sending out a survey to all members via REACH-IT asking participants to sign and return it, indicating whether or not they need to register by 2010.
- By using a declaration of approval that companies have to return as a hard copy or by signing, scanning and posting to the IT platform.
If companies do not respond, the SIEF could move on without them, it was suggested at today's workshop. If they do not accept the agreement – and they are data holders – then they will need to negotiate deals for data sharing with each member themselves.
The SIEF leadership team will propose the basis for financial compensation offered in the bilateral agreement. This should cover reasonable administration charges incurred by the lead registrant and leadership team; the costs of acquiring rights to cite studies in registration dossiers, and the costs of studies undertaken by the SIEF.
CEFIC's lawyers lists three options for this as well but advise that the leadership team chooses one of these to propose rather than open it for discussion with SIEF members:
- Calculation of costs before each deadline with reimbursement by SIEF members when they reach their appropriate registration deadline. Members should be asked to sign the agreement immediately but should not have to make payment until the relevant deadline.
- Partial advance payment to cover the costs of producing the joint submission dossier for 2010 registrants, with the balance payable just before the relevant deadlines.
- Full lump-sum payment to be calculated and paid in advance at the beginning of the process taking into account costs at all deadlines.
The agreement was welcomed by delegates at today's workshop as a way of moving things forward. The hope of CEFIC members is that it will see widespread uptake, facilitating their own need to register in time. However, some feared that it may have come too late to really get SIEFs up and running in time if they have not started.
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30th Sept 08
ECHA offers tools for making REACH registration enquiries
The European Chemicals Agency (ECHA) has made available an 'inquiry dossier preliminary check tool' and a set of questions and answers to help companies more efficiently make enquiries to ECHA, as required by the REACH Regulation, prior to registering non-phase-in substances or phase-in substances that have not been pre-registered. Inquiry dossier preliminary check tool , Inquiry Q&A
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26-Sep-08
ECHA updates guidance on 'only representatives'
The European Chemicals Agency (ECHA) has updated its guidance on the roles and obligations of 'only representatives' in registered substances under REACH. Updated guidance
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24 Sept 08
ECHA launched a new web section to provide information on chemicals
ECHA has launched today a new section, ECHA CHEM, on its website. Under this section you will find public information and documents from REACH processes as they become available. The first information to be published is the Registry of Intentions. The registry will list the intentions of the Member States Competent Authorities / the Commission to submit proposals for 1) identification of Substances of Very High Concern (SVHC), 2) harmonised classification and labelling, and 3) restrictions. The List of Pre-registered substances, the Candidate List of SVHC for authorisation and public information on registered substances will be made available in this web section at later stage.
The public registry of intentions will allow interested parties to become aware of the substances for which the authorities intend to submit such proposals (in the form of an Annex XV dossier). It will also avoid duplication of work and encourage co-operation between Member States when preparing such proposals. Later in the process after the final proposals have been submitted to ECHA interested parties will be able to comment these on the Consultation section of the ECHA website. ECHA will update the Registry of Intentions regularly as it receives submissions from the authorities.
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19th Sep 08
ECHA warns firms breaching REACH pre-registration rules
The European Chemicals Agency (ECHA) has issued a statement warning firms that some are breaching REACH rules and are liable to enforcement actions by Member States. Companies should only pre-register substances they are intending to register, the Agency says.
It points the finger at two companies that have pre-registered the entire EINECS inventory comprising over 100,000 substances, a practice that, the statement says, is in breach of REACH Article 3 (20) which defines 'phase-in' substances. The identity of the two firms is not given, but from a country-by-country breakdown attached to the statement, it can be worked out that the pre-registrations must have come from Germany and the UK.
The Agency is said by outside sources to suspect that such actions may be construed as deliberate acts of sabotage of the REACH implementation process. The statement says: “pre-registration of the entire inventory impacts heavily on the usefulness of the list of pre-registered substances.” It will create disadvantages for downstream users trying to establish whether substances of interest to them have been pre-registered by their supplies, it points out, while the two firms themselves will have an “unmanageable” workload in handling the communication demands of participation in 'substance information exchange fora'.
It says the pre-registrations made by the two firms – and any others that are deleted - will not be included in an intermediate list of pre-registered substances that the Agency intends to publish in October to help downstream users.
As a protective measure, ECHA has now imposed a ceiling of 10,000 as the maximum number of substances a company may pre-register via bulk submission. To pre-register more substances, companies will have to obtain prior approval from the Agency using the 'contact ECHA' form on the 'About ECHA' web page.
ECHA also says that it has received pre-registrations from some 'only representatives' (ORs) that do not meet the conditions of Article 8, which states that the only actors allowed to appoint ORs are non-EU manufacturers, formulators or article producers that export to the EU.
The Agency says it is contacting companies in such cases to check the validity of their pre-registrations. It is also offering firms a route to have pre-registrations deleted in such cases by sending a request by registered mail to:
ECHA, Directorate C/pre-registration team; Annankatu 18, 00121 Helsinki; Finland
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21st Aug 08
Chemical industry launches IT platform to support SIEFs
ReachLink, a new company set up by CEFIC and five other national chemical associations, has launched its first product, SIEFreach, a web-based IT platform designed with IBM to support companies in their Substance Information Exchange Fora (SIEF).
SIEFs are mandated under REACH, but there is no provision in the regulation regarding their management. Their purpose is to reduce costs, minimise animal testing, agree classification and labelling and encourage joint REACH registration. They will be formed after 1 January 2009.
Any company wanting to participate in the platform can upload a substance’s pre-registration data from the European Chemical Agency’s (ECHA) REACH-IT system to SIEFreach. Legal entities can then start using the platform to cooperate and communicate as a pre-SIEF, leading to a SIEF. Ultimately the system aims to support companies to prepare a joint submission of a substance’s REACH registration dossier.
The platform provides free access to ECHA pre-SIEF data for all SIEF participants. Those paying a fee of €300 per legal entity, per substance will have full use of the platform’s functions through to a substance’s registration. These include:
- Discussion areas for topics including substance sameness, available studies, data-sharing and data gaps, cost-sharing and classification and labelling
- Voting and polling capabilities, for the appointment of a SIEF formation facilitator, lead registrant and other decisions
- Break-out areas for invited users to have private discussions
- SIEF status pages to report progress in each topic
- Joint registration submission preparation
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12th Aug 08
ECHA publishes guidance on elements of evaluation, authorisation
The European Chemicals Agency has published two news guidance documents. Guidance on Annex XIV Inclusion describes how the agency, working in co-operation with Member State Competent Authorities, will include substances in the authorisation system. Meanwhile, Guidance on Priority Setting for Evaluation details different methods that have been developed to prioritise dossiers, testing proposals or substances for evaluation and provides guidance for the Agency and Member State Competent Authorities on how to apply these approaches. ECHA website
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