New Rules for Registration of Microbial Biological Control Agents in EU – a Boost for Commercialisation?
Date: 19 September 2022Our biorationals regulatory experts Dr Annerie Liebenberg and Dr Lars Huber examinded the recent changes in the registration process of Microbial Biological Control Agents (MBCAs) and shared their expert opinion with AgroPages in the 2022 Biologicals Special magazine. Read the article online or click here to download it.
Assessment of the Genotoxicity and Carcinogenicity of 2-Chloroethanol Published
Date: 27 July 2022For the current risk assessment of 2-chloroethanol (2-CE) residues in food, Regulation (EC) 396/2005 requires 2-CE to be assessed in the same way as ethylene oxide (EO), which is classified as a genotoxic carcinogen. A group of scientists, including SCC toxicologists Thomas Roth and Henrike Peuschel, have recently assessed the existing genotoxicity and carcinogenicity data and data on structural analogues of 2-CE. They concluded that 2-CE is not a genotoxic carcinogen which makes read-across to EO for risk assessment purposes highly questionable. You can read the online article here.
Update on Extension of UK REACH Transitional Registration Deadlines
Date: 14 July 2022
The Department for Environment, Food & Rural Affairs (Defra) committed already in December 2021 to consider alternative arrangements for the UK REACH Regulation transition periods currently in place.
The government is currently consulting on extending the first submission deadline by three years to 27 October 2026. There are 2 options for the gaps between the two subsequent submission deadlines:
- Option 1: To maintain the 2-year gaps as currently part of the UK REACH regulation, i.e. the submission deadlines would be October 2026, October 2028 and October 2030, depending on tonnage and hazard profile.
- Option 2: To shorten to 1-year gap, i.e. the submission deadlines would be October 2026, October 2027 and October 2028, depending on tonnage and hazard profile.
EU Commission revised the definiton of nanomaterials
Date: 15 June 2022
The EU commission has updated the definition of nanomaterial, which was originally published in the Recommendation 2011/696/EU in 2011. The revised definition is more precise and includes particles with an elongated shape, such as a rod, fibre or tube independent from their chemical composition. The revised definition also provides specifications for particles with a plate like shape and adds a waiver for materials with a specific surface area by volume of < 6 m²/cm³. In the particle definition, single molecules have been excluded.