Preservatives (2nd MAIN GROUP)
Biocidal products are chemical or biological agents used to control, neutralize, or eliminate microorganisms. According to the Biocidal Products Regulation (BPR), numbered 27449 and published on December 31, 2009 (4th Duplicate), biocidal products are divided into four main groups: Disinfectants and General Biocidal Products, Preservatives, Pest Control Products, and Other Biocidal Products. This article focuses on the second main group, "Preservatives."
What is Biocidal 2nd Main Group – Preservatives?
Unless otherwise specified, these product types cover products used only for the prevention of microbial and algal growth.
The product types under the "Preservatives" main group, as listed in Annex V of the Biocidal Products Regulation, are as follows:
- Product Type 6: Preservatives for products during storage
These are products used to maintain the shelf life of manufactured goods (excluding food and feedstuff, cosmetics, or medical devices) by controlling microbial degradation.
This type also includes products used as preservatives in the use or storage of rodenticides, insecticides, or other baits.
- Product Type 7: Film preservatives
Film preservatives are used to protect films or coatings to maintain their initial properties by controlling microbial degradation or algal growth on objects or materials such as paint, plastics, adhesives, wallpaste, binders, paper, or artworks.
- Product Type 8: Wood preservatives
Wood preservatives are used to preserve wood or wood products, including the mill saw phase, against damage or aesthetic impairment caused by organisms, including insects. This product type includes both preventive and curative products.
- Product Type 9: Fiber, leather, rubber, and polymerised material preservatives
Used to preserve fibrous or polymerised materials like leather, rubber, paper, and textiles by controlling microbiological degradation. This type includes biocidal products that resist microorganism colonisation, prevent or hinder odour formation, and/or provide other benefits.
- Product Type 10: Construction material preservatives
These products are used to preserve other construction materials (besides wood), such as walls or composite materials, by controlling microbiological and algal attacks.
- Product Type 11: Preservatives for liquid-cooling and processing systems These products are used to protect water or other liquids in cooling and processing systems against harmful organisms such as microbes, algae, or mussels. Products used to disinfect drinking water or swimming pool water are not included in this type.
- Product Type 12: Slimicides
These products are used to control and prevent slime growth on materials, equipment, and structures used in industrial processes such as wood and pulp, and porous sand strata used in oil extraction.
- Product Type 13: Working or cutting fluid preservatives
These products are used to control microbial degradation of fluids used for working or cutting metal, glass, or other materials.
Licensing Requirements for Preservatives
Preparation of Licensing Dossier
The licensing dossier for preservative products should include the following:
- Biocidal Product License Dossier (as per Annex IIB)
- Biocidal Product Active Substance Dossier (as per Annex IIA)
- Biocidal Product Risk Assessment Report (as per Annex VI)
- Biocidal Product Label (as per Annex XII)
- Biocidal Product Safety Data Sheet (as per Annex II of KKDIK Regulation)
- Biocidal Product Formulation and Specification Documents
- Biocidal Product Packaging Compatibility Declaration
- Biocidal Product Test Results
Testing Requirements
Testing requirements for biocidal products are specified in the Instruction on Biocidal Product Analyses and Authorized Laboratories, published on January 28, 2019, with reference number E.519. According to this instruction, all analyses must be conducted in laboratories accredited with the relevant test parameters or certified under Good Laboratory Practices (GLP).
Biocidal products under preservatives must undergo the following tests:
- Physicochemical Tests
- Short-Term Stability Tests
- Long-Term Stability Tests
- Efficacy Tests
General Provisions on Tests
- All tests must be conducted on samples produced from the same batch/lot number.
- Physicochemical and stability tests should be performed in the same laboratory.
- If efficacy tests are conducted in a different laboratory, the initial physicochemical tests must also be conducted in the same laboratory.
- The efficacy tests must not be older than 10 years from the date of the license application.
Testing Standards
The testing standards specified for preservatives are outlined in Annex 18 of the "Instruction on Biocidal Product Analyses and Authorized Laboratories."
Efficacy tests for preservatives are conducted using suitable methods mentioned in the most recent version of ECHA's publication titled "Guidance on the BPR: Volume II Efficacy, Assessment + Evaluation (Parts B+C)."
Miscellaneous Information on Preservative Product Types
Product Type 6: Preservatives for products during storage
Product Type 6: Preservative Protection Products are used to maintain the shelf life of manufactured products, except for food, feed, cosmetics, medicinal products, or medical devices, by controlling microbial degradation. These products serve as preservatives for the storage or use of rodenticides, insecticides, or other baits.
These preservatives are added during the production of various manufactured products, such as paints, coatings, adhesives, cleaning products, and other industrial materials. By inhibiting microbial growth, Product Type 6 maintains the aesthetic and functional qualities of the products, playing a critical role in ensuring the durability and usability of products over time.
Biocidal products under Product Type 6 are commonly used to protect products during storage. When the preserved product (a chemical substance, mixture, or article) is placed on the market, it is classified as a treated article. Chemical substances and mixtures containing in-can preservatives may be used as components in the production of other finished products. In such cases, if the in-can preservative of the content does not serve any intended biocidal function after the finished product, the preservative residues from the protected content should not lead to the classification of the finished product as a treated article.
Additionally, a solid component used in the production of a complex finished article may include a Product Type 6 preservative. In such instances, it should be considered whether the preservative is related only to the storage process of this component (and not the finished article) or whether the preservative is beneficial for the storage and potential use of the finished article.
Product Type 8: Wood Preservatives
Product Type 8: Wood Preservatives are biocidal products used to prevent destruction and aesthetic deterioration in wood products caused by insects and other pests. These products extend the natural life of wood while preserving its aesthetic appearance. During production, wood preservatives are applied in timber processing and wood product manufacturing to protect against insects, fungi, and other pests.
By preventing decay and biological degradation in wood, these products are particularly utilised in construction, furniture production, and outdoor applications. They ensure the durability and longevity of wood for both indoor and outdoor use.
Biocidal products under Product Type 8 (wood preservatives) are generally used to provide long-term protection for wood, which continues to exhibit this effect in the finished product classified as a treated article. Exceptions to this may be product type 8 biocidal products that are used only during the cutting-chopping stage of the wood or during initial storage or when the wood is treated for remedial purposes before being manufactured as a finished product, and that provide protection against harmful organisms at this stage.
Product Type 9: Fiber, Leather, Rubber, and Polymer Materials
Product Type 9 (PT9) is among the broad classifications of biocidal products and covers products that provide protection for fibre, leather, rubber and polymer materials. These products are used to protect fibrous or polymerized materials, such as leather, rubber, paper, and textiles, by controlling microbial decay. They resist the colonization of microorganisms on materials, thereby preventing or reducing odours and/or providing other benefits. These products are designed to prevent material deterioration and extend their lifespan. By protecting against damage caused by microorganisms, they help maintain the quality of industrial and consumer products.
Biocidal products under Product Type 9 can also be used in the production of treated articles. In this context, if a biocidal product is to be used to extend the service life of a treated article, prevent its deterioration, or protect it from pests, it is necessary to use a licensed biocidal product under Product Type 9 (highlighting its protective content under PT9 on the label and in the market placement of the article).
If you have any questions about your second main group biocidal products, you can contact us at [email protected] or benefit from our Biocidal Product Consultancy service.