EU Regulatory Bulletin contents - October 2014
- EU Commission publishes BPR review programme Regulation
- ECHA issues official Article 95 list of relevant substances, and respective substance and product suppliers
- ECHA publishes a Practical Guide on the Biocidal Products Regulation
- EFSA issues Guidance on the assessment of exposure of operators, workers, residents and bystanders in risk assessment for pesticides
- EU Health Commissioner-designate devoted to final EDC criteria
- REACH Directors’ Contact Group provides recommendations on data costs
The first official Article 95 list of relevant substances, and respective substance and product suppliers in the EU was published by the European Chemical Agency (ECHA) on 24 September 2014. This list represents one of the core changes under the Biocidal Products Regulation 528/2012 (BPR), whereby ECHA is trying to establish a level playing field between data owners and non-data owners such that every market actor contributes to the review of the relevant active substances concerned. Biocidal products cannot be made available on the EU market from 1 September 2015 unless either the active substance or product supplier is on the list for the appropriate active substance/product type (PT) combination.
The document, which is 142 pages long, includes all active substances and their different PTs, such as for example rodenticides and insecticides/acaricides. For each substance/PT combination, there is a list of one or more suppliers. Pertaining to the individual supplier, the following information can be found: company name; country of incorporation; supplier type (i.e. substance supplier and/or product supplier); the reason for inclusion (e.g. participant in the review programme, company supporting a new active, company having submitted a third party dossier); and finally, the inclusion date.
Most participants have been included as substance suppliers, even though they are actually manufacturing and supplying biocidal products. Even if it does not have any direct consequence for them, it could be confusing for formulators of biocidal products looking for authorised substance suppliers included on the list.
It is expected that ECHA will update the list on regular basis (and indeed this list appears to contain some errors). Applications for inclusion on the list can be submitted to ECHA via the R4BP 3. Only companies established in the EU can submit, which means that non-EU companies should appoint a local representative to carry out its submission. Moreover, a recent amendment of the rules allows the names of these non-EU entities to be included in the list next to their EU representatives.
The Article 95 BPR list can be found here.
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