Key Terms
- Biocidal product
- Any substance or mixture intended to destroy, deter, render harmless or control harmful organisms by means other than mere physical or mechanical action, including treated articles with a primary biocidal function [Art. 3(1)(a)].
- Active substance
- A substance or micro-organism that has an action on or against harmful organisms; must be approved at EU level before use in biocidal products [Art. 3(1)(c), Art. 4].
- Treated article
- Any substance, mixture or article that has been treated with, or intentionally incorporates, one or more biocidal products — subject to labelling and active-substance approval requirements [Art. 3(1)(l), Art. 58].
- Candidate for substitution
- An active substance meeting criteria such as PBT borderline properties, respiratory sensitisation or exclusion criteria with derogation, leading to shorter approval periods (max 7 years) and comparative assessment during product authorisation [Art. 10].
- Union authorisation
- An authorisation granted by the European Commission permitting the making available and use of a biocidal product across the entire EU, available for products with similar conditions of use across Member States [Art. 3(1)(n), Art. 42].
- Product-type
- One of 22 categories of biocidal products defined in Annex V, grouped into disinfectants (PT 1–5), preservatives (PT 6–13), pest control (PT 14–20), and other biocidal products (PT 21–22) [Art. 3(1)(q)].
- Substance of concern
- Any non-active substance in a biocidal product with inherent capacity to cause adverse effects on humans, animals or the environment, including substances classified as hazardous, POP, PBT or vPvB [Art. 3(1)(f)].
- Article 95 list
- An ECHA-maintained register of substance and product suppliers with validated dossiers; since 1 September 2015, products may only be marketed if their supplier appears on this list for the relevant product-type [Art. 95].
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Frequently Asked Questions
Which products fall under the Biocidal Products Regulation?
The BPR covers all biocidal products — substances or mixtures intended to destroy, deter, render harmless or control harmful organisms by means other than mere physical or mechanical action — across 22 product-types in four main groups: disinfectants (PT 1–5), preservatives (PT 6–13), pest control (PT 14–20), and other biocidal products including antifouling and embalming (PT 21–22) [Art. 2(1), Annex V]. Treated articles with a primary biocidal function are also classified as biocidal products [Art. 3(1)(a)].
What is the difference between national authorisation and Union authorisation?
A national authorisation is granted by a Member State's competent authority and permits marketing and use in that Member State [Art. 3(1)(m)]. A Union authorisation is granted by the European Commission and permits marketing and use across the entire EU [Art. 3(1)(n), Art. 42]. Union authorisation is available for products with similar conditions of use across the Union but is not available for products containing active substances meeting the exclusion criteria of Art. 5 [Art. 42(1)].
What are the exclusion criteria for active substances?
Active substances classified as carcinogen category 1A or 1B, mutagen category 1A or 1B, toxic for reproduction category 1A or 1B, having endocrine-disrupting properties, or meeting the criteria for PBT or vPvB shall not be approved [Art. 5(1)]. However, derogations exist where exposure is negligible, the substance is essential to prevent serious danger, or non-approval would cause disproportionate societal harm [Art. 5(2)].
What is the ECHA Article 95 list and why does it matter?
The Article 95 list is a register of substance suppliers and product suppliers who have submitted a compliant dossier or letter of access for specific active substances and product-types. Since 1 September 2015, a biocidal product may not be placed on the EU market unless its substance supplier or product supplier is on this list for the relevant product-type [Art. 95(2)]. Falling off the list means immediate loss of market access.
How long is a biocidal product authorisation valid?
An initial authorisation is valid for a maximum of 10 years [Art. 17(4)]. Renewal of approval of an active substance is for up to 15 years [Art. 12(3)], but active substances that are candidates for substitution are limited to 7 years per approval or renewal period [Art. 10(4)].
What labelling is required for treated articles?
Where a biocidal claim is made or the active substance's approval conditions require it, the treated article's label must state that it incorporates biocidal products, identify the biocidal property, name all active substances and any nanomaterials (with 'nano' in brackets), and include instructions for use and precautions [Art. 58(3)]. Even without a claim, the supplier must provide information on the biocidal treatment to any consumer who requests it, free of charge, within 45 days [Art. 58(5)].
What happens when an active substance is not approved after ECHA review?
If an active substance is not approved, Member States may allow continued making available of products containing it for up to 12 months and use of existing stocks for up to 18 months after the non-approval decision [Art. 89(2)]. Where authorisation is refused after an active substance approval, the product must be removed from the market within 180 days and use of existing stocks is permitted for up to 365 days [Art. 89(4)].
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