Significant Amendment to 'Lactic Acid Based' Biocide Approval

Background of the Amendment

Originally, on 26 July 2022, the European Union granted authorisation to CID Lines NV for the market release of their 'Lactic acid-based products'. This approval was contingent on the company conducting long-term storage stability tests and reporting the results to the European Chemicals Agency (ECHA) by 1 March 2023​​.

Key Developments Leading to the Amendment

1. Submission of Test Results: CID Lines NV complied, submitting the required data on time. The Belgian evaluating authority then forwarded its conclusions to ECHA​​.
2. ECHA's Evaluation: On 30 June 2023, ECHA concluded that the data confirmed a shelf life of two years for most products in the family. However, the two-year shelf life for the packaging type 'Wipe 4 2L (105 wipes)' could not be confirmed​​.
3. Agreement on Amendment: The Commission notified CID Lines NV of the intended amendment on 4 August 2023. The company concurred with the amendment proposal regarding the particular packaging type​​.

Impact of the Amendment

A key consequence of this amendment is the removal of the 'Wipe 4 2L (105 wipes)' packaging from the Union authorisation. This decision aligns with the findings that this specific packaging type does not meet the required shelf life criteria​​. The entire Annex II to Implementing Regulation (EU) 2022/1391 has been replaced to reflect this update​​.

Overview of the Biocidal Product Family

The 'Lactic acid based products – CID Lines NV' encompasses various disinfectant products suitable for human hygiene, veterinary hygiene, and use in the food and feed area​​.

• Administrative Details: The authorisation holder is CID Lines NV, based in Belgium. The product family has an authorisation validity extending till 31 August 2032​​.
• Manufacturing Information: CID Lines NV, located in Ieper, Belgium, is the manufacturer of the biocidal products, while the active substance, L-(+)-lactic acid, is manufactured by Purac Biochem bv in the Netherlands​​.
• Composition and Formulation: The product family includes L-(+)-lactic acid and other compounds like Sodium Lauryl sulphate and Sodium lauryl ether sulphate​​.

Safety and Usage Guidelines

• Hazard Statements: The products are known to cause serious eye damage and necessitate wearing eye/face protection​​.
• Authorised Uses: The products are intended for professional use, including hygienic hand wash in the food and feed industry​​.
• Safety Precautions: Users are advised to take immediate safety measures in case of skin, eye, or respiratory contact with the product​​.
• Disposal and Storage: The products must be disposed of as dangerous waste and stored in their original container in a cool, well-ventilated place​​.

One of the products under this family, 'Kenosan Hand Scrub', is specifically designated for the EU market​​.

Stakeholders and users of 'Lactic acid based products – CID Lines NV' should update their practices according to this amendment. It's crucial to adhere to the safety and usage guidelines provided, ensuring compliance with the latest regulatory standards.