The EU Biocidal Products Regulation (BPR) defines a biocide as a substance that destroys or controls a harmful organism by means other than physical or mechanical action.1 Biocidal products and articles treated with biocides are strictly regulated to protect human health and the environment.
Recently, national enforcement authorities in Europe audited over 3,500 biocidal products and determined that 37 percent did not comply with the BPR. All products that contained non-allowed substances or lacked authorization were withdrawn from the market. In some cases, criminal complaints or fines were issued.2 To avoid similar sanctions, companies should ensure the compliance of their products through laboratory testing before bringing biocides to market.
Categorization of biocides
The BPR categorizes biocides into four main groups and further into 22 more specific product types. The main groups and the types of products they cover are summarized below.3
Group 1: Disinfectants
These include products such as hand sanitizers, disinfectants to treat surfaces, algaecides for swimming pools, anti-microbial substances for veterinary use, disinfectants for food preparation, and products to disinfect drinking water.
Group 2: Preservatives
These substances prevent microbial and algal development, which could hasten the degradation of materials. They are used on manufactured products, wood, leather, textiles, rubber, construction materials, industrial machines and processes, and preservative films and coatings for objects like paints, plastics, and paper.
Group 3: Pest control
Products to kill or control rodents, birds, mollusks, worms, fish, and insects are in the pest control category of biocides.
Group 4: Other biocidal products
The final category is a catch-all for miscellaneous biocidal substances, such as embalming fluid and antifouling products for vessels and aquaculture equipment.
Requirements for active substances
Active substances responsible for the biocidal effect must be approved before any product containing them can be authorized for sale in the EU. Typically, approval will not be granted for substances that are carcinogenic, mutagenic, reprotoxic, endocrine disruptors, or persistent, bioaccumulative, and toxic.4
To support an application for the approval of a new active substance, the applicant needs to provide a Core Data Set (CDS) and, where relevant, an Additional Data Set (ADS) on the substance.5 Some of the required information includes the following:
Identity of the active substance and its precursors, including the chemical name, CAS number, and molecular and structural formula
Specification of purity as manufactured
The identity of any impurities and additives including by-products and degradation products
Physical and chemical properties, including UV/VIS, IR, and NMR absorption spectra and a mass spectrum
Data on effectiveness against target organisms
Toxicological profile for humans and animals
The substances that have currently been approved for use in specific types of biocidal products are listed on the European Chemicals Agency’s (ECHA) website. Similarly, ECHA regularly updates and publishes a list of authorized substance and product suppliers.6
Requirements for biocidal products
All biocidal products sold in the EU must only contain active substances purchased from authorized suppliers or listed in Annex I of the BPR. In addition, products must be demonstrably effective against target organisms while not harming the environment, humans, or vertebrates.7
As with active substances, the application for authorization must be supported by a CDS and an ADS comprising data on the composition, physical and chemical properties, toxicological profile, and other relevant characteristics. A simplified authorization procedure applies to products that only contain active substances listed in Annex I, do not contain nanomaterials or substances of concern, are sufficiently effective, and do not require personal protective equipment to be handled safely.
Requirements for biocide-treated articles
Treated articles have a distinct primary function but incorporate or have been treated with one or more biocidal products. Examples include antimicrobial textiles and refrigerators treated with mold-resistant substances. Such articles shall not be placed on the market unless all active substances contained in them are approved and any claims about biocidal properties are substantiated.8
Biocide efficacy testing standards
Proof of effectiveness against target organisms is a key condition for the approval of active substances as well as biocidal products and treated articles. Examples of standardized testing options include the following:
Disinfectant efficacy testing by EN 13727: The test is often required for the approval of hygienic hand rubs, surgical handwashes, surface disinfectants, and other medical industry biocide products.
Evaluation of the antibacterial properties of surfaces by ISO 22196: The standard test is used to evaluate antibacterial activity on plastics and other non-porous surfaces. A modified version can be used for analyzing porous materials.
Textile antibacterial efficacy testing by AATCC 100 or ISO 20743: During the analyses, textiles treated with antibacterial agents are inoculated with bacteria and incubated in warm and humid conditions. Viable bacteria are counted before and after incubation to assess the effectiveness of the biocidal treatment.
Various other standardized and modified test methods are also available. Do not hesitate to ask our experts for more information.
Biocide restrictions in other product groups
EU regulations other than the BPR list the preservatives and disinfectants allowed in specific types of products, such as toys, cosmetics, food, and food contact materials (FCMs). The regulations also place limits on acceptable biocide levels in the end product.
Examples of regulated biocides include isothiazolinones, which can be used in toys, cosmetics, and plastic FCMs, but only subject to conditions outlined in the Toy Safety Directive, the Cosmetics Regulation, and the Plastics Regulation, respectively.
Isothiazolinones may also be used in paper and board FCMs. As there is no EU-wide legislation that would specify content or release limits, German BfR Recommendation XXXVI is generally used to ensure that harmful amounts are not transferred to food.
Table 1. Isothiazolinone limits for toys, cosmetics, and FCMs9
Substance | CAS No | Maximum content in aqueous toy materials | Maximum content in rinse-off cosmetics | Maximum migration from FCMs |
Benzisothiazolinone (BIT) | 2634-33-5 | 5 mg/kg | Not allowed | Plastics: not allowed; Paperboard: 10 µg/dm2 |
Methylchloroisothiazolinone (MCI or CMIT) | 26172-55-4 | 0.75 mg/kg | Only allowed as MCI/MIT mixture | Plastics: not allowed |
Methylisothiazolinone (MIT or MI) | 2682-20-4 | 0.25 mg/kg | 0.0015%* | Plastics: 0.5 mg/kg; Paperboard: 1 µg/dm2 |
3:1 mixture of MCI and MIT | 55965-84-9 | 1 mg/kg | 0.0015%* | Plastics: not allowed; Paperboard: 0.5 µg/dm2 |
* If MIT on its own is used, MCI/MIT mixture is not allowed, and vice versa.
Measurlabs offers a range of biocide testing to help companies verify compliance with European biocide regulations. Examples of popular analyses include isothiazolinone content determination and measurement of the transfer of antimicrobial components from paper and board. If you require biocide testing or have any questions about the topic, please contact us via the form below. One of our experts will get back to you within one business day.
References
1 Article 3, Definitions, of Regulation (EU) No 528/2012.
2 ECHA; One in three checked biocidal products found to be non-compliant; 21 November 2023.
3 Annex V of Regulation (EU) No 528/2012.
4 Approval of active substances, BPR, ECHA.
5 The detailed information requirements are outlined in Annex II of Regulation (EU) No 528/2012.
6 ECHA’s database of active substances and list of active substances and suppliers.
7 See Article 19 of the BPR on the conditions for granting authorization to biocidal products. Annex III specifies the information requirements in more detail.
8 Article 58 of Regulation (EU) No 528/2012 sets out the rules for treated articles.
9 See Appendix C of Directive 2009/48/EC for isothiazolinone limits in toys intended for under 3-year-olds or to be placed in the mouth. The conditions for isothiazolinone use in cosmetics are set in Annex V of Regulation 1223/2009. For FCMs, see FCM Substance No 451 in Annex I of Commission Regulation (EU) No 10/2011 and the English translation of BfR XXXVI.