Biocidal Products Regulation — Regulation (EU) No 528/2012
- Citation
- Regulation (EU) No 528/2012
- Jurisdiction
- EU
- Made by
- European Chemicals Agency
- Instrument
- Regulation
- Status
- In force
What it requires (5 obligations)
A treated article may not be placed on the market unless every active substance in the biocidal products it was treated with, or incorporates, is on the list drawn up under Article 9(2) or in Annex I for the relevant product-type and use, and any conditions or restrictions specified there are met. This is a gate on placing on the market, not a labelling duty: an antimicrobial finish whose active substance is not approved for that product-type bars the article from the market whatever the label says.
No date set Confirmed In force, dates fixed in published law
- Who it falls on
- Manufacturers and importers
- Products
- Textiles, apparel, home textiles
- Markets
- EU
- Entry into force
- 2013-09-01
Article 58(1) limits the whole Article to treated articles that are NOT themselves biocidal products, and excludes articles whose only treatment was fumigation or disinfection of premises or containers with no expected residue. A finished textile carrying an antimicrobial or odour-control treatment sits inside that scope; the biocidal product used to apply it does not.
Drafted from Article 58(2), read verbatim from CELEX 32012R0528 and confirmed unchanged in consolidation 02012R0528-20140425.
Where the manufacturer of a treated article makes a claim about its biocidal properties, or where the conditions attached to approval of the active substance require it, the person responsible for placing the article on the market must ensure the label carries: a statement that the article incorporates biocidal products; the biocidal property claimed, where substantiated; the name of every active substance in those products; the name of any nanomaterial in them followed by the word "nano" in brackets; and any relevant instructions for use, including precautions arising from the treatment.
No date set Confirmed In force, dates fixed in published law
- Who it falls on
- Manufacturers, importers and sellers
- Products
- Textiles, apparel, home textiles
- Markets
- EU
- Entry into force
- 2013-09-01
The trigger is the CLAIM or the approval conditions, not the treatment. A textile treated with an approved active substance and sold with no biocidal claim may carry no Article 58(3) label at all — which is why "does it say anything about odour or freshness on the swing ticket" is the question that decides this duty. The final subparagraph disapplies it where sector-specific legislation already imposes at least equivalent labelling for the same active substances.
Drafted from Article 58(3), first and second subparagraphs, points (a) to (e).
Regardless of whether the Article 58(3) labelling duty is triggered, the person responsible for placing a treated article on the market must label it with any relevant instructions for use, including precautions, where that is necessary to protect humans, animals or the environment.
No date set Confirmed In force, dates fixed in published law
- Who it falls on
- Manufacturers, importers and sellers
- Products
- Textiles, apparel, home textiles
- Markets
- EU
- Entry into force
- 2013-09-01
This is the duty that survives a no-claim product. It is written as a standalone obligation rather than folded into the one above precisely because paragraph 4 is expressed as operating notwithstanding paragraph 3.
Drafted from Article 58(4), which opens "Notwithstanding the labelling requirements set out in paragraph 3".
A supplier of a treated article must, on request from a consumer, provide information on the biocidal treatment of that article within 45 days and free of charge.
No date set Confirmed In force, dates fixed in published law
- Who it falls on
- Traders
- Products
- Textiles, apparel, home textiles
- Markets
- EU
- Entry into force
- 2013-09-01
The duty falls on the supplier rather than the manufacturer, and it is unconditional — it does not depend on a claim having been made or on the Article 58(3) label being required. A brand answering a customer question about a finish is discharging this, whether or not it knows the Article exists.
Drafted from Article 58(5).
The labelling must be clearly visible, easily legible and appropriately durable. Where the size or function of the treated article requires it, the labelling must instead be printed on the packaging, the instructions for use or the warranty, in the official language or languages of the Member State where the article is placed on the market, unless that Member State provides otherwise.
No date set Confirmed In force, dates fixed in published law
- Who it falls on
- Manufacturers, importers and sellers
- Products
- Textiles, apparel, home textiles
- Markets
- EU
- Entry into force
- 2013-09-01
The language duty is per Member State of introduction, so a single EU-wide label satisfies it only where every destination is covered. The Article also allows a manufacturer of articles made to a specific order rather than as a series to agree another method of giving the customer the information — relevant to contract and technical textiles rather than to retail apparel.
Drafted from Article 58(6).
This is a register, not advice. It records what an instrument says and when it applies. Whether it applies to a particular company, product or shipment is a question for somebody who knows that business, and the answer is frequently not what the summary above would suggest.
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