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Article related to: biocides
Does the new Biocides Review Programme Regulation affect you
With the new Biocides regulation that entered into force on 30 October 2014, the Biocides review programme was updated. It clarifies, for example, the use of nano forms and explains when a new active substance/product-type combination can be added to the review programme.
Active substances that may be removed from the review programme
The new regulation lists all the existing active substances that were originally included in the review programme. However, this list is being updated to include only substances for which companies have expressed an interest. You still have time to do this. Therefore, check the list (part two of Annex II) carefully, because the active substances that are there will be removed from the review programme if no company notifies ECHA of their intention to take them over by 31 October 2015. If you use an active substance included in Annex II, you should check with your supply chain that a notification will be made in time in order for you to be able to continue using it.
If you use a nano form of an active substance it needs to be notified as such in order to be introduced in the review programme and to remain on the market. There are two exceptions to this rule – notification is not needed for silver absorbed on silicon dioxide, and silicon dioxide, because nano forms of these two substances are already included in the review programme. Check with your supply chain that a notification will be made by 31 October 2015 for the nano form you use. Otherwise the products will need to be removed from the market.
Can your active substance/ product-type combination be added to the review programme?
In exceptional cases, active substance/product-type combinations can be added to the review programme. This applies to active substances that were already on the market before 14 May 2000, but that were not previously included in the review programme for one of the following reasons:
- If the European Commission or a competent authority has changed its previous advice that the biocidal product was not in the scope of the BPD or that an active substance for a relevant product-type was already notified;
- the active substance benefitted from a derogation for food and feed under the previous regulation; or
- the biocidal product belongs to a different product-type under the BPR compared to the BPD, and contains an active substance that is included in the review programme under the old product-type but not under the new one.
If your active substance/product-type combination fulfils one of these criteria, make a declaration of interest to notify it on ECHA's website. If the declaration is made because of a change of official advice, you need to submit it within 12 months of the clarification. If your case falls under the two latter categories, the declaration of interest must be made by 31 October 2015.
ECHA will publish the active substance/product-type combinations on its website and invite companies to submit a notification. The notification needs to be made within six months from the publication of the active substance/product-type combination.
Adding, changing or removing participants
You can add a new participant to the review programme or replace an existing participant, if all parties agree, by contacting ECHA. However, the new participant has to have a right to refer to all the data that the existing participant has referred to or submitted for evaluation. The new participant will then also be added to the Article 95 list of active substances and suppliers.
If you are identified as a participant in the review programme but you no longer use the active substance, you can also withdraw your participation.
New, quicker deadlines
To make sure that all the active substances included in the review programme are assessed by 2024, the new regulation defines legal deadlines for Member States to evaluate them. These deadlines can be found in Annex III of the regulation.
How to notify?
If you want to notify the use of a nano form or an interest in an active substance that is currently without any participant, you need to create a IUCLID dossier and submit it using R4BP 3. There is a fee for the notification, but this will be deducted from the amount you have to pay when you later apply for approval of the active substance/product-type combinations. The application needs to be submitted within two years after ECHA has confirmed that your notification is compliant.
If you want to include a substance in the review programme, you first need to declare an interest through a webform and later notify by submitting a IUCLID dossier through R4BP 3.
If you want to join, replace or withdraw a participant in the review programme, use one of the dedicated web forms available on ECHA's website.
Review Programme Regulation (EU) No 1062/2014 under Implementing and delegated acts
- Existing active substances
- Declaring interest to notify a substance for inclusion in the review programme
- Joining or replacing a participant
- Withdrawing a participant
- Biocides terminology – in 23 languages
The review programme was set up by the European Commission under the Biocidal Products Directive (BPD). It is the work programme for the examination of biocidal active substances. These active substances were on the market on 14 May 2000 in biocidal products (for purposes other than scientific or product and process-orientated research and development).
The original Review Programme Regulation was replaced by Regulation (EU) No 1062/2014 which entered into force on 30 October 2014. Biocidal products containing substances in the review programme are allowed to be on the market without an authorisation (pending approval of the substance), subject to national laws.
Text by Päivi Jokiniemi
Top image: Fotolia
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Committee for Socio-Economic
1-4 and 8-11 June (tentative);
7-11 and 14-18 September (tentative)
Committee for Risk Assessment:
1-5 and 8-12 June;
7-11 and 14-18 September (tentative)
Member State Committee:
Biocidal Products Committee:
Management Board meeting: