Ask Dr REACH: Do biocides need to be registered under REACH
QUESTION: "Do biocides need to be registered under REACH?" The questioner is a global speciality chemicals manufacturer based in the USA that also exports to the EU.
ANSWER:
Care must be taken in considering the interaction between REACH and other legislation. Biocides, for instance, though already regulated, are only partially exempted from REACH.
It is always useful and appropriate to refer back to the actual legal text. The status of biocidal products is explicitly covered under Articles 15(2) on registration and 56(4) on authorisation.
Active substances in biocides are considered as ‘registered’ under REACH but only if they are specifically included under the scope of the EU 1998 biocidal products Directive (BPD) or the corresponding European Commission Regulation on the second-phase of the Directive’s work programme.
Other component substances of a biocidal product may be subject to registration. Any use of the active substance outside the BPD can also fall within the scope of registration under REACH. The current understanding is that the tonnage of substance used for non-biocidal applications must be registered separately.
Even the active substances covered by the BPD may need to be part of other processes under REACH, such as data sharing and communication through the supply chain. Data holders under the BPD may therefore want to prepare to sell or exchange data with users of a substance. In practice, data holders first need to consider the extent to which any shared ownership or data access that they have negotiated for the BPD can be used for other purposes.
Actual uses of substances within the scope of the BPD are, however, excluded from REACH ‘authorisation’ requirements. Here, the exclusion appears to cover all the ingredients in a biocidal product rather than being limited to the active substances.
Unlike ‘notified substances’ – i.e. those previously subject to the EU 1967 Directive on the notification of new substances – active biocidal substances, as they are regarded as already registered, need not submit information updates under REACH. However, they will need to follow the rules of the BPD in such cases.
Steffen Erler
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.
