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.
Echa calling SMEs for verification of their company size information in REACH-IT
Date: 10 May 2022
Echa calls on SME registrants to verify the information on their company size they provided while registering their substance. If micro, small or medium-sized companies have incorrectly declared their company size, they can provide amended information at sme-verification(at)echa.europa.eu by 31 May 2022, by uploading the required documents supporting their claim in REACH-IT. By correcting the company information before Echa starts its audit, companies can save the administrative fee, worth up to € 19.900.
Echa advises registrants to regularly check their REACH-IT accounts for new messages and tasks and keep their registrations and data up-to-date.
Update of REACH: Only Representatives Must Declare Their Non-EU Manufacturers
Date: 5 May 2022
The European Commission has updated the information requirements for Only Representatives (OR), as provided in Annex VI of REACH, and is requiring ORs to identify the non-EU manufacturers they represent and provide the contact information in REACH-IT starting from April 26 and to be completed by 14 October 2022. OR must also have a separate REACH-IT account for each non-EU manufacturer they represent, including if the OR also acts as manufacturer/importer under REACH.
Upcoming Important Changes to REACH Information Requirements
Date: 5 May 2022
An important revision to REACH has been recently published by the European Commission. This revision will apply from October 14, 2022.
The main changes are related to:
New Developments on REACH Polymers Regulation
Date: 11 April 2022
The CARACAL subgroup on polymers published important new information on the upcoming REACH Polymers Regulation, which dramatically changes the EU Commission’s position discussed so far. CARACAL now proposes a 1-step process and to identify only Polymers Requiring Registration (PRRs), while polymer of low concern (PLC) properties shall not be used as a criteria anymore. The new approach will be subject to ongoing discussions in further meetings of the CARACAL subgroup and with stakeholders.
Organisational and Personnel Changes in Our Agrochemical Business
Date: 1 April 2022
In order to continue the expansion of our support for our customers, we have decided to make the following organisational changes. Together with these strategic changes we continue to set our course for the future.
We have decided to combine our Agrochemicals and Biorationals business Unit with our Regulatory Science business Unit into one joint and combined Department. This change will take place as of 1st April 2022. The aim is to strategically develop our Agrochemical business area and also to continue to strengthen our existing strong support and assistance for our clients and customers.
To take measures to implement our new strategy and drive the successful integration of these two business Units, we have recruited Dr Dagmar Heibertshausen as the new Head of the joint Department.
Dr Heibertshausen is an agricultural biologist and she completed her doctorate at the University of Giessen in cooperation with the Research Institute for Horticulture and Viticulture in Geisenheim.
For the last 12 years, she worked for an agricultural multinational business in the Regulatory Affairs Department, and recently as Director of Regulatory Affairs Europe, responsible for their active substances.
We would like to warmly welcome Dr Heibertshausen to the SCC family and look forward to working together with her.
SCC's archives re-confirmed as GLP compliant
Date: 3 February 2022
We are happy to announce that SCC has successfully passed the Good Laboratory Practice (GLP) inspection and confirmed its status as a contract archive certified to perform archiving in compliance with the Principles of GLP.
The inspection was carried out on 5 October 2021. Further to this inspection, the statement of GLP compliance was issued by the Landesamt für Umwelt in Mainz in Germany on 11 January 2022. The national GLP Compliance Programme holds provisions for inspections on a regular basis which are held every three years. Visit our GLP website to find out more about our services.
BoA decision on tonnage downgrade, assessment of regulatory needs and update from CARACAL
Date: 1 February 2022
Recently, there have been several regulatory updates with an impact on the European chemicals market. We have summarised for you the key aspects and conclusions on the following topics, which you can find on our regulatory guidance website:
- Board of Appeal permits a tonnage downgrade after draft compliance check decision
- Assessment of Regulatory Needs List – All You Need to Know
- Update from CARACAL on the ongoing DMELs study and the upcoming REACH revision