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Regulatory Framework and Definitions
Biocidal products are governed under the BPR (Regulation No. 528/2012), which defines them as any substance or mixture designed to control harmful organisms in various forms, excluding mere physical or mechanical actions. The regulation categorizes 22 product types into four main groups:
- Disinfectants for human or veterinary hygiene.
- Preservatives to prevent microbial or algae growth.
- Pest Control products.
- Other biocidal products not fitting into the previous categories.
These products contain active substances (AS), which are key ingredients designed to combat harmful organisms. An active substance can be either chemical or microbial.
Labelling Requirements
One of the most critical aspects of placing biocidal products on the market is ensuring that their labels are compliant with the BPR and related regulations like CLP Regulation (Classification, Labelling, and Packaging of substances and mixtures). Non-compliant labelling can lead to significant penalties, including market withdrawal.
According to Article 69 of the BPR, labels must contain mandatory information. In addition to these requirements, specific national provisions exist in certain EU countries. For example:
- In Belgium, labels must be in French, German, and Dutch and include provisional authorization numbers.
- Spain mandates specific warnings for products used in human hygiene.
- In Italy, the label must include the manufacturer's details and be marked with the term "Presidio medico chirurgico."
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Prohibited and Discouraged Claims
Biocidal product claims must not mislead the consumer. Article 69 prohibits certain misleading terms, such as:
- "Low-risk biocidal product."
- "Non-toxic."
- "Harmless."
- "Natural" or "Environmentally friendly."
Additionally, terms like "natural" and "vegan" are discouraged as they can imply unjustified safety or efficacy benefits. Claims about natural origin or ecological impact are not permitted if they conflict with the product's classification under safety regulations.
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Advertising Requirements
Under Article 72 of the BPR, advertising claims must follow similar rules to labelling. They must not include terms such as "non-toxic" or "harmless" and must always advise consumers to "use biocides safely" and to "read the label and product information before use."
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Best Practices for Making Claims
Every claim made on a biocidal product label or in advertising must be substantiated by reliable data. Some examples include:
- Efficacy claims: Products claiming to be effective against specific organisms like viruses, algae, or fungi must have supporting tests. For instance, EN16777 for viruses and EN13697 for fungal spores.
- Expiry date claims: These must be backed by stability tests, both accelerated and long-term. For example, a claim of a 3-year shelf life must be supported by 3-year stability testing.
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Compliance Tips from Regulatory Authorities
The regulatory authorities in the EU, such as those in France, have provided practical resources to help businesses comply with these labelling rules. For example, in 2021, a compliance inspection of biocidal products in France revealed that 40% of the inspected products had labelling non-conformities. In response, France issued practical labelling guidelines in 2022, focusing on both the authorisation and transitional periods.
Compliance with the BPR's labelling and advertising rules is crucial for biocidal products in the EU. Proper labelling ensures not only legal compliance but also public safety, as consumers rely on this information for correct and safe product use. With strict penalties in place for non-compliance, manufacturers must pay close attention to regulatory updates and ensure that all claims made about their products are supported by robust data.
Need assistance ensuring the compliance of your biocidal products? Schedule a meeting with our experts today and receive personalized advice. Click here to book an appointment!
Regulatory Framework and Definitions
Biocidal products are governed under the BPR (Regulation No. 528/2012), which defines them as any substance or mixture designed to control harmful organisms in various forms, excluding mere physical or mechanical actions. The regulation categorizes 22 product types into four main groups:
- Disinfectants for human or veterinary hygiene.
- Preservatives to prevent microbial or algae growth.
- Pest Control products.
- Other biocidal products not fitting into the previous categories.
These products contain active substances (AS), which are key ingredients designed to combat harmful organisms. An active substance can be either chemical or microbial.
Labelling Requirements
One of the most critical aspects of placing biocidal products on the market is ensuring that their labels are compliant with the BPR and related regulations like CLP Regulation (Classification, Labelling, and Packaging of substances and mixtures). Non-compliant labelling can lead to significant penalties, including market withdrawal.
According to Article 69 of the BPR, labels must contain mandatory information. In addition to these requirements, specific national provisions exist in certain EU countries. For example:
- In Belgium, labels must be in French, German, and Dutch and include provisional authorization numbers.
- Spain mandates specific warnings for products used in human hygiene.
- In Italy, the label must include the manufacturer's details and be marked with the term "Presidio medico chirurgico."
_
Prohibited and Discouraged Claims
Biocidal product claims must not mislead the consumer. Article 69 prohibits certain misleading terms, such as:
- "Low-risk biocidal product."
- "Non-toxic."
- "Harmless."
- "Natural" or "Environmentally friendly."
Additionally, terms like "natural" and "vegan" are discouraged as they can imply unjustified safety or efficacy benefits. Claims about natural origin or ecological impact are not permitted if they conflict with the product's classification under safety regulations.
_
Advertising Requirements
Under Article 72 of the BPR, advertising claims must follow similar rules to labelling. They must not include terms such as "non-toxic" or "harmless" and must always advise consumers to "use biocides safely" and to "read the label and product information before use."
_
Best Practices for Making Claims
Every claim made on a biocidal product label or in advertising must be substantiated by reliable data. Some examples include:
- Efficacy claims: Products claiming to be effective against specific organisms like viruses, algae, or fungi must have supporting tests. For instance, EN16777 for viruses and EN13697 for fungal spores.
- Expiry date claims: These must be backed by stability tests, both accelerated and long-term. For example, a claim of a 3-year shelf life must be supported by 3-year stability testing.
_
Compliance Tips from Regulatory Authorities
The regulatory authorities in the EU, such as those in France, have provided practical resources to help businesses comply with these labelling rules. For example, in 2021, a compliance inspection of biocidal products in France revealed that 40% of the inspected products had labelling non-conformities. In response, France issued practical labelling guidelines in 2022, focusing on both the authorisation and transitional periods.
Compliance with the BPR's labelling and advertising rules is crucial for biocidal products in the EU. Proper labelling ensures not only legal compliance but also public safety, as consumers rely on this information for correct and safe product use. With strict penalties in place for non-compliance, manufacturers must pay close attention to regulatory updates and ensure that all claims made about their products are supported by robust data.
Need assistance ensuring the compliance of your biocidal products? Schedule a meeting with our experts today and receive personalized advice. Click here to book an appointment!
