Biocidal Products Regulation: what a treated article is, the label it needs, and who may sell a biocide in the EU

The Biocidal Products Regulation, Regulation (EU) No 528/2012Regulation (EU) No 528/2012, Biocidal Products Regulation (consolidated text of 19 August 2026)The whole regulationClick opens the law on the EU Publications Office., sets the EU rules for products that kill or control harmful organisms such as bacteria, mould and pests, and for articles treated with them (Art. 2(1)Regulation (EU) No 528/2012, Biocidal Products Regulation (consolidated text of 19 August 2026)Article 2, paragraph 1Click opens the article on EUR-Lex., consolidated text of 19 August 2026). Most online sellers meet its second half. A sock sold as anti-odour, a shirt sold as antibacterial or a paint sold as mould-resistant is a “treated article”, and the rule for it sits on the active substance in the biocide, not on the product.

What counts as a treated article, and what does not

A treated article is “any substance, mixture or article which has been treated with, or intentionally incorporates, one or more biocidal products” (Art. 3(1)(l)Regulation (EU) No 528/2012, Biocidal Products Regulation (consolidated text of 19 August 2026)Article 3, paragraph 1, point (l)Click opens the article on EUR-Lex.). A biocidal product is a substance or mixture that consists of, contains or generates an active substance “with the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical action”. A treated article that has a primary biocidal function “shall be considered a biocidal product” (Art. 3(1)(a)Regulation (EU) No 528/2012, Biocidal Products Regulation (consolidated text of 19 August 2026)Article 3, paragraph 1, point (a)Click opens the article on EUR-Lex.). The lines fall like this.

An antibacterial claim carries one more consequence. The Commission’s note for guidance says claims such as “Antibacterial”, “Kills 99% bacteria” and “Provide antibacterial protection” show a biocidal function. Weighed with the article’s other properties, functions and intended uses, that function “could be considered as a primary biocidal function”, and then the treated article “would be regarded as a biocidal product and would have to be authorised as such”. A statement such as “contains a preservative against microbial deterioration” is a claim about biocidal properties, not about biocidal function (Commission, note for guidance on treated articles).

The Regulation also leaves out biocidal products and treated articles that fall within the scope of listed laws, among them the Cosmetic Products Regulation, the Toy Safety Directive 2009/48/EC, the medical device and in vitro diagnostic directives, and the laws on medicines, food hygiene, food additives, flavourings and feed, and plant protection products. The exclusion is “subject to any explicit provision to the contrary”, and where a biocidal product within one of those laws is used for a purpose that law does not cover, the BPR applies to that purpose (Art. 2(2)Regulation (EU) No 528/2012, Biocidal Products Regulation (consolidated text of 19 August 2026)Article 2, paragraph 2Click opens the article on EUR-Lex.). A cosmetic is therefore under the EU Cosmetics Regulation, a medical device under the Medical Device Regulation.

Only approved active substances may be in the biocide

The rule on the article itself is one sentence. A treated article “shall not be placed on the market unless all active substances contained in the biocidal products that it was treated with or incorporates” are on the Union list of approved active substances “for the relevant product-type and use”, or in Annex I, “and any conditions or restrictions specified therein are met” (Art. 58(2)Regulation (EU) No 528/2012, Biocidal Products Regulation (consolidated text of 19 August 2026)Article 58, paragraph 2Click opens the article on EUR-Lex.).

Three words in it do the work.

• Product-type. An approval is given per product-type, from Annex V: a substance approved as a film preservative on paint (product-type 7) is not thereby approved for a fibre against odour (product-type 9) (Art. 4(2)Regulation (EU) No 528/2012, Biocidal Products Regulation (consolidated text of 19 August 2026)Article 4, paragraph 2Click opens the article on EUR-Lex.).
• Use. The test is the use of the article too, not the product-type alone.
• Conditions. An approval can carry conditions, and the article has to meet them (Art. 4(3)Regulation (EU) No 528/2012, Biocidal Products Regulation (consolidated text of 19 August 2026)Article 4, paragraph 3Click opens the article on EUR-Lex.).

This rule reaches imports. Under the earlier law, articles imported from outside the EU could be treated with substances not allowed in the EU. The Regulation ended that: the Commission says that mixtures and articles “can only be treated with active substances that have been approved in the EU for that purpose”, and ECHA’s example of the old gap is sofas and shoes containing DMF (Commission, treated articles; ECHA, treated articles).

A substance not yet approved can still be lawful, for a time. Article 94Regulation (EU) No 528/2012, Biocidal Products Regulation (consolidated text of 19 August 2026)Article 94Click opens the article on EUR-Lex. lets a treated article stay on the market while the substance is under examination. This is how the status reads for the substance in your biocide:

ECHA keeps a list of the substance and product-type combinations that qualify, the “Article 94 list” on its treated articles page. The copy read here has the status of 5 November 2025. ECHA says in it that the list is voluntary and “neither mandated by law, nor does it produce any legally binding effects”. It has three parts: substances approved or under examination, withdrawn combinations whose 180 days have not run out, and substances newly notified for the review programme. It names the combination; the table above gives the date.

When the label is due and what it says

The label duty falls on “the person responsible for the placing on the market of a treated article”, and only in two cases (Art. 58(3)Regulation (EU) No 528/2012, Biocidal Products Regulation (consolidated text of 19 August 2026)Article 58, paragraph 3Click opens the article on EUR-Lex.):

• a claim is made about the biocidal properties of the article. The Article names the manufacturer as the one who makes it, but the Commission’s note for guidance says the BPR “does not specify where a claim has to be made”, so a claim in the technical documentation counts too; or
• the conditions of the approval of the active substance require it, having regard to contact with people or release into the environment.

ECHA reads the first case plainly: “Labelling is always required when an article refers to biocidal properties”. Its own example of an article that does is “textiles treated with silver for antibacterial purposes” (ECHA, In brief: treated articles).

When the duty applies, the label carries five parts:

The label must be “clearly visible, easily legible and appropriately durable”. Where the size or the function of the article requires it, it goes on the packaging, the instructions for use or the warranty, in the official language or languages of the EU country of introduction, unless that country provides otherwise (Art. 58(6)Regulation (EU) No 528/2012, Biocidal Products Regulation (consolidated text of 19 August 2026)Article 58, paragraph 6Click opens the article on EUR-Lex.). An article made to one customer’s order, not in a series, may carry the information by another method the manufacturer agrees with the customer. The duty does not apply where equivalent labelling is already required by sector-specific law for the same active substances (Art. 58(3)Regulation (EU) No 528/2012, Biocidal Products Regulation (consolidated text of 19 August 2026)Article 58, paragraph 3Click opens the article on EUR-Lex.).

The label duty is tied to placing on the market. The Commission’s note says it “concerns the ‘placing on the market’, but not the subsequent supply”, and that companies further down the supply chain “have no further obligations” except the 45-day answer. A business that takes the article into a new treated article and places that on the market has the label duty for the new one.

A separate line sits beside it: if it is necessary to protect people, animals or the environment, the article is labelled with any relevant instructions for use, including precautions, whether or not a claim is made (Art. 58(4)Regulation (EU) No 528/2012, Biocidal Products Regulation (consolidated text of 19 August 2026)Article 58, paragraph 4Click opens the article on EUR-Lex.).

The consumer’s right to information within 45 days

“The supplier of a treated article shall, where a consumer so requests, provide that consumer, within 45 days, free of charge, with information on the biocidal treatment of the treated article” (Art. 58(5)Regulation (EU) No 528/2012, Biocidal Products Regulation (consolidated text of 19 August 2026)Article 58, paragraph 5Click opens the article on EUR-Lex.). The paragraph opens “Notwithstanding the labelling requirements”, so it stands apart from the label: it applies whether or not the article has a label under Art. 58(3)Regulation (EU) No 528/2012, Biocidal Products Regulation (consolidated text of 19 August 2026)Article 58, paragraph 3Click opens the article on EUR-Lex.. The Commission and ECHA both state it the same way.

You can only answer if your supplier has told you which biocide the article holds. That makes the supplier statement in step 2 the document you keep. The same 45 days appears in the REACH rule for substances of very high concern, a different duty with different information; an article can trigger both. The REACH side is in SVHC and REACH compliance.

Who carries the duties when the seller is outside the EU

The Regulation puts the label on “the person responsible for the placing on the market”, and placing on the market is “the first making available on the market” of the article (Art. 58(3)Regulation (EU) No 528/2012, Biocidal Products Regulation (consolidated text of 19 August 2026)Article 58, paragraph 3Click opens the article on EUR-Lex., Art. 3(1)(j)Regulation (EU) No 528/2012, Biocidal Products Regulation (consolidated text of 19 August 2026)Article 3, paragraph 1, point (j)Click opens the article on EUR-Lex.). ECHA and the Commission both say the labelling duty is on manufacturers and importers of treated articles, and ECHA adds that the duties on treated articles apply to importers of articles too, “a significant change” from the earlier law.

The BPR is on the list of Union harmonisation legislation in Annex I to Regulation (EU) 2019/1020Regulation (EU) 2019/1020, Market Surveillance RegulationThe whole regulationClick opens the law on the EU Publications Office. (point 41), so that Regulation’s market surveillance and border rules apply to it (Art. 2(1)Regulation (EU) 2019/1020, Market Surveillance RegulationArticle 2, paragraph 1Click opens the article on EUR-Lex., Art. 25(3)Regulation (EU) 2019/1020, Market Surveillance RegulationArticle 25, paragraph 3Click opens the article on EUR-Lex.). The BPR is not among the laws in Art. 4(5)Regulation (EU) 2019/1020, Market Surveillance RegulationArticle 4, paragraph 5Click opens the article on EUR-Lex. of that Regulation, so its own rule requiring an EU-based operator does not come from the BPR. For consumer goods, GPSR has its own rule on an EU-based contact, set out in the EU Responsible Person.

Biocidal products need an authorisation before they are sold

“Biocidal products shall not be made available on the market or used unless authorised in accordance with this Regulation” (Art. 17(1)Regulation (EU) No 528/2012, Biocidal Products Regulation (consolidated text of 19 August 2026)Article 17, paragraph 1Click opens the article on EUR-Lex.). It is a two-step system: the active substance is approved at EU level, then every product that holds it is authorised for its formulation, its use and its user group, usually by the EU country where it is sold (Commission, biocidal products). An authorisation can be granted for a single product or a product family and lasts at most ten years (Art. 17(3)Regulation (EU) No 528/2012, Biocidal Products Regulation (consolidated text of 19 August 2026)Article 17, paragraph 3Click opens the article on EUR-Lex., Art. 17(4)Regulation (EU) No 528/2012, Biocidal Products Regulation (consolidated text of 19 August 2026)Article 17, paragraph 4Click opens the article on EUR-Lex.).

The application is made “by, or on behalf of, the prospective authorisation holder”, and the holder is “the person established within the Union who is responsible for the placing on the market of a biocidal product” (Art. 17(2)Regulation (EU) No 528/2012, Biocidal Products Regulation (consolidated text of 19 August 2026)Article 17, paragraph 2Click opens the article on EUR-Lex., Art. 3(1)(p)Regulation (EU) No 528/2012, Biocidal Products Regulation (consolidated text of 19 August 2026)Article 3, paragraph 1, point (p)Click opens the article on EUR-Lex.). A company outside the EU therefore does not hold an authorisation. It sells through an EU-established holder.

The rows rest on Art. 17(2)Regulation (EU) No 528/2012, Biocidal Products Regulation (consolidated text of 19 August 2026)Article 17, paragraph 2Click opens the article on EUR-Lex., Art. 3(1)(n)Regulation (EU) No 528/2012, Biocidal Products Regulation (consolidated text of 19 August 2026)Article 3, paragraph 1, point (n)Click opens the article on EUR-Lex., Art. 25Regulation (EU) No 528/2012, Biocidal Products Regulation (consolidated text of 19 August 2026)Article 25Click opens the article on EUR-Lex., Art. 26(1)Regulation (EU) No 528/2012, Biocidal Products Regulation (consolidated text of 19 August 2026)Article 26, paragraph 1Click opens the article on EUR-Lex., Art. 27(1)Regulation (EU) No 528/2012, Biocidal Products Regulation (consolidated text of 19 August 2026)Article 27, paragraph 1Click opens the article on EUR-Lex. and Art. 42(1)Regulation (EU) No 528/2012, Biocidal Products Regulation (consolidated text of 19 August 2026)Article 42, paragraph 1Click opens the article on EUR-Lex.. An authorisation requires the active substances to be in Annex I or approved for the product-type (Art. 19(1)(a)Regulation (EU) No 528/2012, Biocidal Products Regulation (consolidated text of 19 August 2026)Article 19, paragraph 1, point (a)Click opens the article on EUR-Lex.).

Three more rules reach a seller of biocidal products online.

• Label and advertising. The authorisation holder labels the product in line with the approved product characteristics; the label may not carry “low-risk biocidal product”, “non-toxic”, “harmless”, “natural”, “environmentally friendly”, “animal friendly” or a similar indication (Art. 69(1)Regulation (EU) No 528/2012, Biocidal Products Regulation (consolidated text of 19 August 2026)Article 69, paragraph 1Click opens the article on EUR-Lex., Art. 69(2)Regulation (EU) No 528/2012, Biocidal Products Regulation (consolidated text of 19 August 2026)Article 69, paragraph 2Click opens the article on EUR-Lex.). An advertisement must include “Use biocides safely. Always read the label and product information before use.” and may swap “biocides” for the product-type, and it carries the same list of banned words (Art. 72(1)Regulation (EU) No 528/2012, Biocidal Products Regulation (consolidated text of 19 August 2026)Article 72, paragraph 1Click opens the article on EUR-Lex., Art. 72(3)Regulation (EU) No 528/2012, Biocidal Products Regulation (consolidated text of 19 August 2026)Article 72, paragraph 3Click opens the article on EUR-Lex.).
• Safety data sheet. One is prepared and made available under the REACH rule, where applicable (Art. 70Regulation (EU) No 528/2012, Biocidal Products Regulation (consolidated text of 19 August 2026)Article 70Click opens the article on EUR-Lex.). See the safety data sheet guide.
• Transition. For existing active substances still under examination, an EU country may keep its own system for making a product available for up to three years after the date of approval of the last of its active substances (Art. 89(2)Regulation (EU) No 528/2012, Biocidal Products Regulation (consolidated text of 19 August 2026)Article 89, paragraph 2Click opens the article on EUR-Lex.). Two cut-offs apply. If no application for authorisation was filed by the approval date, the product may no longer be made available from 180 days after that date (Art. 89(3)Regulation (EU) No 528/2012, Biocidal Products Regulation (consolidated text of 19 August 2026)Article 89, paragraph 3Click opens the article on EUR-Lex.). After a decision not to approve a substance, the country may continue for only up to 12 months, for making available (Art. 89(2)Regulation (EU) No 528/2012, Biocidal Products Regulation (consolidated text of 19 August 2026)Article 89, paragraph 2Click opens the article on EUR-Lex.). ECHA states the same: products with review-programme substances can be made available, “subject to national laws”, pending the decision (ECHA, Understanding BPR).

The Article 95 list is a second gate on the product

ECHA publishes a list of the active substances that have a complete dossier accepted, and of the persons who submitted it or a right to use it (Art. 95(1)Regulation (EU) No 528/2012, Biocidal Products Regulation (consolidated text of 19 August 2026)Article 95, paragraph 1Click opens the article on EUR-Lex.). A person established in the EU who manufactures or imports such a substance is a “substance supplier”. A person established in the EU who manufactures or makes available a biocidal product holding it is a “product supplier”. Either may file a complete dossier, a letter of access to one, or a reference to one whose data protection has expired.

The gate is in Art. 95(2)Regulation (EU) No 528/2012, Biocidal Products Regulation (consolidated text of 19 August 2026)Article 95, paragraph 2Click opens the article on EUR-Lex.: since 1 September 2015 a biocidal product that holds a listed substance “shall not be made available on the market unless either the substance supplier or the product supplier is included in the list” for its product-type. The gate does not apply to substances in Annex I categories 1 to 5 and 7, or to products holding only those (Art. 95(6)Regulation (EU) No 528/2012, Biocidal Products Regulation (consolidated text of 19 August 2026)Article 95, paragraph 6Click opens the article on EUR-Lex.). A listed supplier that is not an applicant in a renewal of the approval is removed from the list if it files no letter of access to the relevant data within 12 months of the renewal (Art. 95(7)Regulation (EU) No 528/2012, Biocidal Products Regulation (consolidated text of 19 August 2026)Article 95, paragraph 7Click opens the article on EUR-Lex.).

ECHA’s Article 95 list carries the names. The PDF is “deemed authentic”; the spreadsheet is a courtesy copy. The copy read here is dated 28 August 2025. For a company outside the EU, ECHA says the Article 95 rules extend to Norway, Iceland, Liechtenstein and Switzerland, and that companies established outside those countries and the EU “have the option – it is non-compulsory – to be represented by an EU representative” and be shown on the list next to that representative (ECHA, Active substances and suppliers).

Article 95 applies to biocidal products. A treated article is outside it (Art. 58(1)Regulation (EU) No 528/2012, Biocidal Products Regulation (consolidated text of 19 August 2026)Article 58, paragraph 1Click opens the article on EUR-Lex., Art. 95(2)Regulation (EU) No 528/2012, Biocidal Products Regulation (consolidated text of 19 August 2026)Article 95, paragraph 2Click opens the article on EUR-Lex.).

What happens if you do nothing

A treated article with an active substance that is not approved, and not covered by Article 94, may not be placed on the market at all (Art. 58(2)Regulation (EU) No 528/2012, Biocidal Products Regulation (consolidated text of 19 August 2026)Article 58, paragraph 2Click opens the article on EUR-Lex.). EU countries monitor biocidal products and treated articles on the market, and each sets penalties that must be “effective, proportionate and dissuasive” (Art. 65(1)Regulation (EU) No 528/2012, Biocidal Products Regulation (consolidated text of 19 August 2026)Article 65, paragraph 1Click opens the article on EUR-Lex., Art. 87Regulation (EU) No 528/2012, Biocidal Products Regulation (consolidated text of 19 August 2026)Article 87Click opens the article on EUR-Lex.). Market surveillance authorities can require you to bring the product into compliance, stop it being made available, withdraw or recall it, or destroy it (Art. 16(3)Regulation (EU) 2019/1020, Market Surveillance RegulationArticle 16, paragraph 3Click opens the article on EUR-Lex. of Regulation (EU) 2019/1020). At the border, customs suspend release of a product that is not labelled as Union law requires, or where there is cause to believe it does not comply (Art. 26(1)Regulation (EU) 2019/1020, Market Surveillance RegulationArticle 26, paragraph 1Click opens the article on EUR-Lex. of Regulation (EU) 2019/1020).

The Commission is evaluating the BPR, and no revision is proposed

The Commission is evaluating whether the Regulation is fit for purpose. A call for evidence and a public consultation ran from 11 December 2025 to 5 March 2026, an outside study began in July 2026, and the evaluation is to be finished by the end of 2027. Depending on what it finds, an impact assessment for a revision might follow (Commission, evaluation of the BPR). Nothing in it changes the rules above today.

What the law leaves open

• Who the “person responsible for the placing on the market” is when a parcel goes from a seller outside the EU straight to an EU consumer. Art. 58(3)Regulation (EU) No 528/2012, Biocidal Products Regulation (consolidated text of 19 August 2026)Article 58, paragraph 3Click opens the article on EUR-Lex. names no role, and the BPR defines no importer. ECHA and the Commission speak of manufacturers and importers. The rule on active substances in Art. 58(2)Regulation (EU) No 528/2012, Biocidal Products Regulation (consolidated text of 19 August 2026)Article 58, paragraph 2Click opens the article on EUR-Lex. binds the article regardless of the answer. Meanwhile, know each active substance in the biocide, label if you claim a biocidal effect, and answer consumer requests as a supplier would. On this route no other operator makes the first supply.
• Who the “supplier” of Art. 58(5)Regulation (EU) No 528/2012, Biocidal Products Regulation (consolidated text of 19 August 2026)Article 58, paragraph 5Click opens the article on EUR-Lex. is. The BPR defines “supplier” only for Art. 95Regulation (EU) No 528/2012, Biocidal Products Regulation (consolidated text of 19 August 2026)Article 95Click opens the article on EUR-Lex.. Whether a seller outside the EU is a supplier for the 45-day answer is not stated.
• Whether a given product is a biocidal product, a treated article or neither. The Commission can decide this for a specific product or group of products by implementing act, at the request of an EU country (Art. 3(3)Regulation (EU) No 528/2012, Biocidal Products Regulation (consolidated text of 19 August 2026)Article 3, paragraph 3Click opens the article on EUR-Lex.). No decision of that kind is named on the pages read here.

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