Over the years I’ve visited many retail premises including pharmacies across Ireland, and one thing has become clear: most compliance issues don’t arise because retailers ignore the law, they arise because they don’t realise a product is regulated as a biocide in the first place.
Whether you operate a pharmacy, hardware store, agricultural merchant, builders’ providers, garden centre or convenience store, there is a good chance you already stock products that are regulated as biocidal products. Many retailers are surprised to learn that products as familiar as disinfectants, wood preservatives, rodenticides and insecticide products fall within a specialised regulatory framework.
The sale of biocidal products in Ireland is governed by European legislation and Irish national legislation. Understanding your responsibilities is essential, not only to remain compliant with the law but also to ensure that customers are supplied with products that are safe, effective and legally authorised for the Irish market.
A biocidal product is any substance or mixture intended to destroy, deter, render harmless, prevent the action of, or otherwise control harmful organisms by means other than purely physical or mechanical action.
Simply put, if a product is designed to control bacteria, viruses, fungi, insects, rodents, algae or other harmful organisms through a chemical or biological action, it is likely to be a biocidal product.
Common examples found in pharmacy outlets include:
Other examples of products which may be found in pharmacy outlets include:
Not every product that claims to clean or disinfect is necessarily regulated in the same way, so retailers should always check if a product is registered to allow them to purchase the product. Some products may appear similar but are regulated under different legislation, such as plant protection products, cosmetics, veterinary medicines, human medicines or detergents. When in doubt, retailers should seek confirmation from their supplier, or check the biocidal products register.
If your business sells disinfectants, insecticides, rodenticides, wood preservatives or other products designed to control harmful organisms, then the answer is almost certainly yes.
Many Irish pharmacies are unaware that these everyday products are regulated under one of the European Union’s most comprehensive pieces of chemicals legislation. While manufacturers and importers carry much of the responsibility for obtaining approvals, pharmacies also have important legal obligations when placing biocidal products on the Irish market.
Fortunately, compliance is not as daunting as it may first appear. By understanding a few key principles, pharmacies can confidently stock and sell biocidal products while meeting both European and Irish legal requirements.
The sale and supply of biocidal products throughout the European Union is governed by Regulation (EU) No. 528/2012, commonly known as the Biocidal Products Regulation (BPR).
The purpose of the Regulation is to ensure that products made available on the market are both effective and safe for people, animals and the environment.
In Ireland, these requirements are enforced through the European Union (Biocidal Products) Regulations 2013 (S.I. No. 427 of 2013). The Pesticide Controls Division (PCD) of the Department of Agriculture, Food and the Marine is the Irish Competent Authority (CA) and are responsible for all pieces of legislation linked to pesticides, they are also responsible for enforcement.
A common misconception is that retailers such as pharmacies have little responsibility because manufacturers obtain the product authorisations. In reality, retailers play an important role in ensuring that only compliant products reach consumers.
Retailers should satisfy themselves that every biocidal product offered for sale is registered for the Irish market. The easiest way to achieve this is by purchasing from reputable suppliers who understand Irish regulatory requirements.
Care should be taken with products sourced from overseas wholesalers or online suppliers, as products authorised in one country are not automatically approved for sale in the Republic of Ireland. Particular care should be taken when purchasing from third countries such as the UK which are no longer part of the European Regulatory system and may not be registered for sale and use in Ireland.
The product label is much more than marketing material; it is a legal document. An approved product label contains essential information as specified on Art 69 of the BPR, including:
Products should never be sold with damaged, altered or incomplete labels.
Not every biocidal product is intended for the general public. Some products are authorised exclusively for industrial, professional or trained professional users. Staff should understand any restrictions applying to the products they sell and ensure that customers receive products appropriate to their intended use. Some products such as professional use and trained professional use rodenticides have requirements for retailers to keep records of goods in/goods out and ensure they only sell to users that can prove their competence.
Good stock management is also part of good compliance. Retailers should:
These simple measures help protect staff, customers and the environment.
Advertising for biocidal products is also regulated under Art.\ 72 of the BPR. Any advertisement (including online) of biocidal products should include the following sentences, and they must be clearly distinguishable and legible in relation to the whole advertisement, “Use Biocides safely. Always read the label and product information before use”. Advertisements must not mislead consumers regarding the risks posed by the product with respect to human health, animal health or the environment or its efficacy. The legislation specifically prohibits claims such as:
Whether advertising in-store, online or on social media, retailers should ensure that promotional material reflects the approved product claims. If a retailer claims additional uses not listed on the product label, this could result in a biocidal product non-compliance. An advertisement could incorrectly add biocidal claims to a cosmetic etc. product, and those claims on the advertisement of the product would have serious implications for that product, which would be removed from sale on enforcement. Retailers should also ensure that promotional materials supplied by manufacturers comply with these requirements before using them in-store or online.
Selling through websites or online marketplaces does not remove regulatory obligations. Products sold online into Ireland must meet the same legal requirements as products sold over the counter.
Retailers should ensure that online descriptions accurately reflect the authorised label and avoid making claims that go beyond the approved uses. Where online descriptions go beyond the approved uses/claims on the label, it could bring a borderline product within scope of the BPR, resulting in a full market recall for that product.
Authorised officers from the Pesticide Controls Division (PCD) of the Department of Agriculture, Food and the Marine may inspect retail premises to verify compliance with the legislation.
During an inspection, officers may examine:
Retailers who maintain good purchasing records and source products through reputable suppliers generally find inspections straightforward.
The BPR ensures a level playing field for manufacturers in this regulated industry, it ensures only safe and effective products are available for sale. Failure to comply with the legislation may result in enforcement action ranging from advice and corrective measures through to prosecution, depending on the seriousness of the offence.
Beyond the legal consequences, selling unauthorised products can expose retailers to significant reputational damage and potential liability if products cause harm. Customers increasingly expect retailers to supply products that are both effective and legally compliant. Good compliance is therefore an investment in both customer confidence and business resilience.
A few simple steps can greatly reduce compliance risks:
Biocidal products perform an essential role in protecting public health, agriculture, buildings and the wider environment. Because these products are designed to control living organisms, they are subject to robust regulation throughout Europe.
For retailers, compliance does not require specialist legal knowledge. By purchasing from trusted suppliers, checking product authorisations, understanding product labels and ensuring staff receive basic awareness training, businesses can confidently meet their obligations under European and Irish legislation.
You may have more questions on the biocidal product labels and the biocidal products register and how to review them, this will be addressed in the next issue.
Six questions every retailer (pharmacy) should ask their supplier:
✔ Is this product approved (notified or authorised) for sale in Ireland?
✔ Can you provide the Irish or EU registration number or confirmation of its legal status?
✔ Is the product labelled in accordance with Irish and EU requirements?
✔ Do I need to keep records of goods in/goods out for this product?
✔ Is this product intended for trained professional users, professional users, the general public, or all of the above?
✔ Will you notify us if the product authorisation changes, expires or is withdrawn?
Michelle Whelan PhD
Biocides Enforcement, Pesticide Controls Division, Department of Agriculture, Food and the Marine
Highlighted Articles
