What is an active substance?
An Active Substance or AS is defined as a “substance or micro-organism that has an action on or against harmful organisms (other than by physical or mechanical action).” They are found in biocidal products (BP) such as mosquito repellents or hydroalcoholic gels.
In order to limit risks to human health and the environment, ASs must be pre-approved in order to place a BP on the market.
Biocidal AS evaluation is made at the European level and by product type (PT)
For each AS to be assessed, the applicant may choose a Member State to evaluate his dossier. Once the application is valid (if the dossier is full), the competent authority submits its conclusions to ECHA within 365 days. ECHA then has 270 days to give its opinion and submit it to the European Commission that will approve or not the substance.
Several types of Active Substance/Product Type (AS/PT) couples are distinguished according to their assessment:
- Existing AS/PT pairs being evaluated
- The new AS/PT couples
- Approved AS/PT couples
- Unapproved AS/PT couples
Existing AS/PT pairs being evaluated
In this context, the ASs were placed on the market before 14th May 2000 and are being evaluated (by product type). The existing ASs that could be considered under the review programme are those that have been identified as such and for which a notification has been accepted. These substances are listed in Regulation (EU) No 1062/2014 on the review programme in relation to the BP Regulation.
BPs that contain this type of AS benefit from the transitional period during which they can stay on the market, provided that they have carried out the necessary steps specific to each Member State (transitional measures).
Existing AS/PT pairs being evaluated may be approved for a maximum of 10 years and the renewal of this approval may not exceed 15 years.
New AS/PT couples
ASs are not included in the review programme (Regulation (EU) No 1062/2014). The AS/PT couple must therefore be approved. In the meantime, products belonging to this PT and containing this AS cannot be placed on the market. For this to be possible, a provisional application for Marketing Authorisation (MA) will be required. The latter will only be valid for a maximum period of 3 years.
Approved AS/PT couples
The European Commission has approved the AS/PT couple. The AS can be used, for the defined PT, for a maximum duration of 10 years. The renewal of this approval may not exceed a period of 15 years. An application for Marketing Authorisation (MA) will be required for the biocidal product.
Unapproved AS/PT couples
The European Commission has disapproved the AS/PT couple. If the product was on the market under the transitional measures, the product could be made available for another 12 months and used 18 months after the opinion of the European Commission.
To learn more about the MA, do not hesitate to consult our blog post on the subject.
