At the recent Rapra REACH USA 2009 conference, representatives from consultancies and companies immersed in consortia stressed that, practically speaking, only 18 months remain before the first registration deadline.
Unless companies have consortia agreements already in place or close to finalisation, they risk missing the December 2010 deadline, at least as part of joint registrations. Consequently, companies are looking at business risk mitigation measures and alternative registration scenarios.
Following pre-registration, companies will have been assigned to pre-substance information exchange fora (pre-SIEFs). The next step will be to form a SIEF via a SIEF formation facilitator. This will typically occur through a 'sameness of substance' (SOS) check. Communication between pre-SIEF members may require purchasing access to an appropriate IT interface or using alternative methods.
Sameness of substance
Due to the tight timelines, there will be pressure to find ways to streamline data and cost-sharing in order to ensure registrations are successful. As a consequence, in some instances it may be appropriate to consider a substance as the same without actually reviewing data on substance identification by the different pre-registrants.
For some substances it is possible to theoretically conduct SOS checks and apply the criteria on a case-by-case basis when considering the relevance of study results for data-sharing. In many cases this depends on manufacturing process, sources of raw materials or a combination of these two factors.
Proceeding from pre-SIEF to SIEF data-sharing with or without a SIEF formation facilitator - may therefore be possible. Obviously, the implications and consequences must be fully analysed and accounted for. But realising when this is possible is critical to registration strategy.
The primary purpose of data-sharing under REACH can often be overlooked by analytical chemists and technical experts. Data-sharing relates to endpoints on toxicology, ecotoxicology and environmental fate.
Substances are considered to be the same if studies on the REACH Annex endpoints are relevant across pre-registrations. Analytical data alone cannot answer sameness questions. Companies and consultancies should frequently remind themselves of this in order to remain focused on the scope and objective of data-sharing.
A key to securing registration is ensuring that minimum data-sets are available to submit a dossier. The REACH Regulation does not prevent a company from generating Annex VII and VIII data, as long as it does not involve vertebrate animal studies and appropriate steps are taken.
Fundamentally, the lower Annex testing requirements drive the entire safety assessment process. Costs and timelines for registration can only be predicted by compiling and assessing existing data. For example, a chemical safety assessment can easily take anywhere between one day and five years!
Knowledge of intrinsic chemical properties therefore enables a substance registration to be managed. Without this corporate strategies cannot be formed.
Receiving new, unexpected or conflicting data late in a safety assessment can give rise to major technical problems. For instance, an exposure assessment can be triggered by a change in a substance classification from 'non-dangerous' to 'dangerous'. Performing an exposure assessment does however require considerable time, which must be planned.
'Existing' data must always be sufficiently robust to be included in a registration data-set. They will need reviewing to determine, for instance, whether ' an appropriate test guideline was followed when performing the test. Searching through archived data presents a significant task in itself - one of the many unaccounted costs of REACH. It is therefore critical to perform such activities early on.
Managers must also be aware that performing a study can be easier and less-costly than reaching agreement on the validity of 'existing' data. Where conflicting information exists, repeating a non-vertebrate study may be an appropriate option.
Whether independently or part of a SIEF, testing must be planned in collaboration with an appropriately selected laboratory. Conducting a study is the simple part, if appropriately planned. Costs and timing estimates must take into account a number of critical factors, such as analytical method development, range finders and data interpretation.
The quality of a study becomes critical given the time constraints of REACH. Data submitted in a registration dossier will form the basis for safety assessments. If further testing is identified as necessary, for instance to reduce conservative default assessment factors, test proposals must be first approved by ECHA, which can take several years.
This fact reinforces the need for robust and understood base-set data, which requires a high level of expertise for conducting and interpreting studies. A single study for REACH could end up determining risk management measures and dictating the future economic viability of a substance on the EU market.
It is therefore appropriate to ask from the outset of forming a SIEF:
- What is the timeline and cost to complete a registration dossier?
- What if the registration process results in a change of classification?
- What are the implications if a registration deadline is missed?
Legal Disclaimer: The information contained in this communication follows a technical interpretation of REACH to serve as a thought-starter for discussions; it does not constitute legal or any other form of advice. Note that technical aspects are subject to review and references should be checked for updates. The legal text of the REACH Regulation must serve as the basis for REACH compliance and it may be advisable to seek legal and/or other expert advice on any given issue. The author and Chemical Watch accept no liability whatsoever with regard to the use of information contained in this communication.