Key Terms
- Biocidal product
- Any substance or mixture intended to destroy, deter, render harmless, prevent the action of, or otherwise exert a controlling effect on any harmful organism by means other than mere physical or mechanical action [Art. 3(1)(a)].
- Active substance
- A substance or micro-organism that has an action on or against harmful organisms. The BPR distinguishes between existing active substances (on the market before 14 May 2000) and new active substances [Art. 3(1)(c)–(e)].
- Treated article
- Any substance, mixture or article which has been treated with, or intentionally incorporates, one or more biocidal products. Subject to placing-on-the-market and labelling requirements under Art. 58 [Art. 3(1)(l)].
- Product-type
- One of the 22 categories of biocidal products listed in Annex V, grouped into four main groups: disinfectants (PT 1–5), preservatives (PT 6–13), pest control (PT 14–20), and other biocidal products (PT 21–22) [Art. 3(1)(q)].
- Union authorisation
- An administrative act by which the European Commission authorises the making available on the market and use of a biocidal product across the entire EU territory, as an alternative to national authorisation plus mutual recognition [Art. 3(1)(n), Art. 42].
- Candidate for substitution
- An active substance that meets at least one of the criteria in Art. 10(1) (e.g. exclusion criteria met but derogation applied, or significantly lower ADI than most approved alternatives). Subject to comparative assessment and shorter approval/authorisation periods [Art. 10, Art. 23].
- Substance of concern
- Any non-active substance in a biocidal product with inherent capacity to cause adverse effects on humans, animals or the environment, present in sufficient concentration to pose a risk — typically substances classified as hazardous under CLP or meeting PBT/vPvB criteria [Art. 3(1)(f)].
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Frequently Asked Questions
What is the difference between a biocidal product and a treated article under the BPR?
A biocidal product is a substance or mixture intended to destroy, deter or control harmful organisms [Art. 3(1)(a)]. A treated article is any substance, mixture or article that has been treated with or intentionally incorporates one or more biocidal products [Art. 3(1)(l)]. The key distinction: a treated article with a primary biocidal function is classified as a biocidal product and needs full authorisation [Art. 3(1)(a), last subparagraph]. A treated article without primary biocidal function must still comply with Art. 58 (approved active substances, labelling).
Do I need authorisation for every EU Member State separately?
Not necessarily. The BPR offers three pathways: national authorisation in a single Member State [Art. 17], mutual recognition to extend that authorisation to other Member States in sequence or in parallel [Art. 33, Art. 34], and Union authorisation valid across the entire EU [Art. 42]. For simplified-procedure products (Annex I substances only), authorisation is valid in all Member States with a 30-day notification requirement [Art. 27(1)].
What is the Article 95 list and why does it matter?
The Article 95 list is ECHA's publicly available register of substance suppliers and product suppliers who have submitted a compliant dossier or letter of access for relevant active substances [Art. 95(1)]. Since 1 September 2015, a biocidal product may not be made available on the EU market unless its substance supplier or product supplier is on this list for the relevant product-type [Art. 95(2)]. Failure to appear on the list means an effective market ban.
Which active substances are excluded from approval?
Active substances meeting any of these criteria are excluded: classified as carcinogen category 1A or 1B, mutagen category 1A or 1B, or toxic for reproduction category 1A or 1B under Regulation (EC) No 1272/2008; identified as having endocrine-disrupting properties for humans; or meeting PBT or vPvB criteria under REACH Annex XIII [Art. 5(1)]. A narrow derogation allows approval if exposure is negligible, the substance is essential to prevent a serious danger, or non-approval would cause disproportionate negative impact on society [Art. 5(2)].
What labelling obligations apply to treated articles?
When a treated article makes a biocidal claim or the active substance approval conditions require it (e.g. due to contact/release risk), the label must state: (a) that the article incorporates biocidal products, (b) the biocidal property attributed to it, (c) the names of all active substances, (d) any nanomaterials followed by '(nano)', and (e) relevant instructions for use and precautions [Art. 58(3)]. Even without a biocidal claim, labelling with precautionary instructions is mandatory where necessary to protect humans, animals or the environment [Art. 58(4)]. On consumer request, information on biocidal treatment must be provided within 45 days free of charge [Art. 58(5)].
How long does a biocidal product authorisation last?
A standard authorisation is granted for a maximum of 10 years [Art. 17(4)]. For products containing active substances that are candidates for substitution, the maximum is five years [Art. 23(6)]. Active substance approval is granted for a maximum of 10 years initially (five years for substances meeting exclusion criteria), with renewals of up to 15 years (seven years for candidates for substitution) [Art. 4(1), Art. 10(4), Art. 12(3)].
What happens to products containing active substances still under the review programme?
Under Article 89(2), Member States may continue to apply their national systems for biocidal products containing existing active substances that are still being evaluated, until three years after the date of approval of the last active substance in that product. If no authorisation application is submitted, the product must be withdrawn from the market within 180 days of the approval date, and existing stocks may be used for up to 365 days [Art. 89(3)]. The review programme itself has been extended to 31 December 2030 by Delegated Regulation (EU) 2024/1398.
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