The European Chemicals Agency (ECHA) held its tenth Stakeholders’ Day at their Conference Center in Helsinki, Finland, on May 27th with over 260 participants. The main topics included the upcoming REACH (Registration, Evaluation and Authorization of Chemical Substances) 2018 deadline, how to improve the quality of the dossiers, and successful compliance checks.
By 2018, companies manufacturing or importing chemicals of ≥ 1 t per year need to have registered their substances. Many small- and medium-sized enterprises that have little experience with REACH are expected to be among these registrants. ECHA has received 48,000 registrations, 2,309 for new substances, and 6 million classification and labelling notifications for over 110,000 substances. It is expected that these numbers will be even greater for the 2018 deadline. The Agency is preparing for these next challenges by improving the user-friendliness of their web tools; by streamlining the authorization and biocidals related processes; and by cooperating with the Member States, accrediting stakeholders, and other European networks to support and reach out to companies that might not be aware of their obligations.
During the event, tips were given to first-time registrants for successful registration. For example, that they should start registering as soon as possible, as registration is not an easy process and takes time. It was also recommended, that first-time registrants wait for the release of the revised versions of the software IUCLID 6 in mid-2016. This software is used to compile regulatory data on chemicals and to submit the dossiers. Newcomers were advised to use the readily available help, such as the national help desks and the REACH 2018 website, and decide on their testing strategy. The latter included the suggestion of partnering with third-party consultants and laboratories if a company does not have the necessary expertise.
Identification of Substances
Dr. Stuard Niven, Harlan Laboratories Ltd., Switzerland, explained how good substance identification is done for lead and co-registration dossiers. Under REACH a substance is defined as “a chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition”.
REACH requires the identification and naming of two main groups of substances: (i) well-defined substances, which are substances with a defined qualitative and quantitative composition, and (ii) UVCB substances, which are substances of Unknown or Variable composition, Complex reaction products, or Biological materials.
To decide whether a well-defined substance should be considered as mono-constituent or multi-constituent, the so-called “80%- 20 %” and “80%-10 %” rules are applied. A substance is considered a mono-constituent if the main component is ≥ 80 %. All impurities ≥ 1 % have to be identified and named, if hazardous, all those ≥ 0.1 %. The composition must add up to 100 %. For multi-constituent substances, the main components are present in concentrations between ≥ 10 % and < 80 %. Impurities are possible. For UVCB substances all compounds ≥ 10 % have to be identified and named.
The full identification of a substance under REACH requires information on the chemical composition of the substances and the chemical identity of the constituent(s) by means of IUPAC name plus other identifiers when available, such as EC number or CAS number. For UVCB substances, information on the source and manufacturing process is also necessary. In addition, molecular and structural information and spectral and analytical data sufficient to confirm the structure and the composition of the substance are needed. Niven concluded that overall, it is important to aim to justify and not to comply.
Sari Haukka, ECHA, explained what to consider when preparing an appeal. The independent Board of Appeal within ECHA can be addressed with legal pleas and claims against ECHA decisions listed in Article 91 of REACH. An appeal fee has to be paid on own initiative before the board starts their work. The amount varies depending on the type of decision that is being appealed against.
Dr. Martin Kayser, BASF SE, Ludwigshafen, Germany, looked at the user experience of REACH. BASF is the leading REACH registrant. It has submitted more than 600 dossiers for phase 1 and more than 500 for phase 2. For many of these substances, BASF is the lead or only registrant. It represents 50 legal entities within the EU and 40 legal entities outside the EU. BASF employs 30 REACH coordinators in operating divisions, 130 substance coordinators, 70 toxicologists, ecotoxicologists, and other experts working on dossier preparation. In addition, it uses external consultants.
BASF has submitted more than 2000 regulatory/business-driven dossier updates, received 341 decision letters, and 113 of their substances are subject to the Community Rolling Action Plan (CoRAP) evaluation process. Still, it has only limited experience with the process, as it, so far, have received only ten final decisions with recommendations or requirements for new testing, five final decisions with no additional testing requirements, and about 50 draft decisions.
According to Kayser, the process in general works. Cooperation with the Member State Competent Authorities (MSCAs) has proven fruitful and industry has gained experience in more efficient communication and documentation.
However, he also showed with examples where BASF sees room for improvement and is optimistic that this will happen. Practicability should be increased, bureaucracy should be decreased, and formalistic approaches should be replaced by practical and good science-based approaches. It is critical for the quality and the efficiency of the process that the input of industry is adequately taken into account and considered early on.
From industry’s point of view, weak points include the fact that processes are running in parallel, such as a request for an update and an evaluation, that they receive conflicting messages, such as to perform animal testing under REACH, which is not allowed according to cosmetics regulation and may lead to a marketing ban. They also stated that too many details and questionable requirements are required and the weight of evidence was dismissed. For example, BASF was asked to replace an old Ames test, which was submitted together with full genotoxicity data, with a new one, only because the test now consisted of five instead of four strains of bacteria and this is required in the new guidelines. The Ames test determines whether a given chemical can cause mutations in the DNA of a test organism.
BASF thinks it is essential that industry is consulted before the Risk Management Option Analysis (RMOA) is done. Industry knows their substances, even though they may not always agree on the interpretation of the data and the results, so to get their perspective and input early on may save time. The Public Activities Coordination Tool (PACT) is seen as a good first step to initiate this cooperation.
In concluding, he said that we need an agreement on scientific principles, a pragmatic and workable approach, well-experienced evaluators on both sides, a level of pragmatism that does not overburden industry and, of course, that shows credible results. Kayser hopes that this is a learning process and that we will become better and advance further on the learning curve, as in his opinion we all agree that at the end the process should lead to scientifically sound substance evaluations.
Other topics addressed at the meeting included the necessity of good supply-chain communication to generate realistic exposure scenarios, how to prepare for a successful application for authorization, how to avoid pitfalls, how authorities are picking substances for risk management, and what to avoid while your substance is being evaluated.
The Stakeholders’ Day was followed by the Helsinki Chemicals Forum (HCF), which discussed the future of the global chemical risk management.
- European Chemicals Agency (ECHA), Helsinki, Finland
- 10th Stakeholders’ Day: Presentations and Webstream
- ECHA Helpdesk
- REACH 2018: Know your portfolio and start preparing now