EU BPR: Preservative approvals are on the horizon, and it’s time to get ready
Several preservative active substances are currently under review under the EU’s Biocidal Products Regulation (BPR), and could be approved within 14 months. Preservatives can pose risks to human health that may create challenges for BPR risk assessments. Therefore, it’s advisable to get a head start on BPR product dossier planning and preparation by assessing the uses of your preservatives, identifying worst-case exposure scenarios and finding solutions to reach an acceptable level of exposure. Starting early can help avoid undesirable outcomes of the BPR evaluation that may impose more restricted uses, reformulation requirements or complete loss of products down the line.
Assessing the uses of preservatives
In-can preservatives are key ingredients for avoiding spoilage of products. Added to mainly water-based products that are susceptible to microbial contamination – such as varnishes, paints and adhesives – they preserve them during manufacture, transportation, and storage. Such mixtures treated with a preservative are defined as ‘treated articles’ under the Biocidal Product Regulation (BPR) No 528/2012.
Other preservatives include biocidal products intended to protect materials (wood, fibre, polymers, masonry), as well as protective agents for liquids in cooling and processing systems and in working and cutting fluids. They are also used in industrial processes (e.g. paper-making) as slimicides. The use of preservatives in food and cosmetics is not in scope of the BPR.
Identifying worst-case exposure scenarios
Sensitisation and labelling of treated articles
Preservatives are typically used by industry during the manufacture of treated articles. While use of these biocidal products by the general public is not expected, people can be exposed to treated articles containing a biocidal product (e.g., a paint containing an in-can preservative).
Isothiazolinones (ISZ) are some of the most widely used preservatives in detergents, paints and consumer products, as they are efficacious against a broad spectrum of microorganisms at relatively low concentrations. However, ISZs are potent skin sensitisers. Their presence can result in the classification of biocidal products and can trigger labelling requirements for treated articles.
To protect the general public, specific conditions such as the restrictions for downstream uses (biocidal products and treated articles) may be found in the decisions approving biocidal active substances. Where consumer use is a key business area and acceptable levels of exposure are difficult to achieve, other solutions will need to be sought.
Safety concerns in industry
Based on risk, approval and authorisation of a preservative may be dependent on the use of personal protective equipment (PPE). If an active substance is hazardous by inhalation or classified as a respiratory sensitiser, or if specific concentration limits are set for its use, the biocidal product and associated treated articles may need to be labelled as sensitisers.
However, not all industrial workers can wear PPE. For instance, metalworkers using turning machines do not typically wear gloves due to the need for dexterity. This can result in direct contact with metal working fluids. In addition, the emission of aerosols, either from the machine operations or the use of cutting fluids in aerosol form, can be hazardous to health. Under BPR these complex exposure scenarios must be assessed to show acceptable uses for the products.
Over the last 15 years, as regulation of biocides has increased, the number of available preservative active substances has decreased significantly. However, approvals are expected for the following substances in the coming years:
- BIT CAS No 2634-33-5 (expected October 2023)
- L-(+)-lactic acid CAS No 79-33-4 (expected November 2023)
- Formic acid CAS No 64-18-6 (expected June 2024)
- Reaction products of paraformaldehyde and 2-hydroxypropylamine (ratio 1:1; HPT) and (ratio 3:2; MBO) (expected June 2024)
Companies placing preservative formulations on the EU market are advised to make a start on BPR product dossier planning and preparation now to avoid potential challenges during the BPR risk assessment.
How TSG can help
Our consultants have many years’ experience helping clients navigate BPR requirements. We have a strong track record in active substance applications and successful EU registrations for a wide range of products and use areas.
With new approvals of preservative active substances on the horizon, we can help you get ahead by:
- Assessing the uses of your preservative, identifying worst-case exposure scenarios, including for treated articles, and finding solutions to reach acceptable level of exposure
- Handling or supporting biocidal product dossier preparation and submission
- Post-submission support and communications with regulatory authorities
- Finding sustainable solutions
Contact us to find out more: [email protected]