07 Nov October Regulatory Updates
Recent Regulatory Developments in Biocidal Active Substances:
The European Union has recently published a series of regulatory updates concerning the approval and non-approval of certain active substances for use in biocidal products.
Two implementing regulations have been published, approving a complex reaction mass of various ammonium propionate compounds for use in biocidal products:
- Implementing Regulation (EU) 2023/2088 approves the substance for use in product-type 8 biocides, effective from October 19, 2023. This active substance was previously approved under a different name, which has now been updated to reflect its correct chemical identity.
- Implementing Regulation (EU) 2023/2089 extends the approval to include product-types 2 and 4 biocides, also effective from October 19, 2023.
Conversely, two decisions have been made to not approve certain active substances:
- Implementing Decision (EU) 2023/2052 does not approve silver sodium hydrogen zirconium phosphate for use in product-type 4 biocides, with the decision taking effect on October 16, 2023.
- Implementing Decision (EU) 2023/2377 does not approve silver and copper zeolite for use in product-type 4 biocides, effective from October 23, 2023.
Extensions on Approval Expiry Dates
The European Commission has also published decisions to extend the approval expiry dates for several active substances pending renewal decisions:
- Implementing Decision (EU) 2023/2100 extends the approval of copper (II) oxide for product-type 8 biocides until October 19, 2023.
- Implementing Decision (EU) 2023/2378 extends the approval of alfa-chloralose for product-type 14 biocides until October 23, 2023.
- Implementing Decision (EU) 2023/2380 extends the approval of basic copper carbonate for product-type 8 biocides until October 22, 2023.
- Implementing Decision (EU) 2023/2386 extends the approval of copper hydroxide for product-type 8 biocides until October 22, 2023.
These extensions have been granted as applications for renewal were submitted in a timely manner, and the decisions on renewal are pending.
- The European Chemicals Agency (ECHA) is preparing to propose restrictions on certain high-concern chromium (VI) substances, currently listed for authorization under REACH. This action, requested by the European Commission, is to manage the heavy workload from numerous authorization applications and to prevent potential resource strain on ECHA’s risk assessment committees. The proposal, due by October 2024, could lead to the removal of these substances from the REACH Authorisation List for the first time. The substances are known carcinogens and have other serious health risks, commonly used in electroplating. Companies affected by these potential restrictions can consult a Q&A document published by the Commission for guidance.
- Switzerland is set to update its chemical regulations to exempt specific uses of five substances listed under the EU’s REACH Annex XIV. The Swiss Federal Office for the Environment (FOEN) aims to align more closely with EU regulations by amending the Chemical Risk Reduction Ordinance (ORRChem). This change, which was reported to the WTO at the end of October, involves adding these substances to a Swiss annex that mirrors the EU’s authorization requirements for Substances of Very High Concern (SVHCs).
- The substances in question include three that are toxic to reproduction: tetraethyllead (used in fuels), DOTE (used in polymers), and a reaction mass of DOTE and MOTE.
- The other two are a carcinogen used in inks and toners, known as:4,4′-bis(dimethylamino)-4”-(methylamino)trityl alcohol (with traces of Michler’s ketone or Michler’s base), and an endocrine disruptor for the environment, which is a reaction product of certain chemicals (with a specific percentage of 4-heptylphenol).
- The updated regulation is expected to be officially adopted on the first day of the new year and will come into effect on January 1, 2027. This follows a previous amendment in April where Switzerland granted exemptions for the use of SVHCs in the pharmaceutical and aircraft industries.
EU Parliament Votes for Stricter Asbestos Exposure Limits:
- The European Parliament has taken a significant step towards enhancing worker safety by voting to reduce the occupational exposure limit (OEL) for asbestos by ten times. The new directive, which garnered overwhelming support with 614 votes in favor, aims to lower the OEL from 0.1 to 0.01 fibers per cubic centimeter. This move is part of the EU’s broader strategy to combat the risks posed by asbestos, a known carcinogen.
- The directive mandates stringent measures, including the use of protective gear, specialized respiratory equipment, and comprehensive training for workers dealing with asbestos. Additionally, within six years, EU member states are required to provide workers with advanced electron microscopes capable of detecting asbestos fibers at the new lower concentration levels.
- Despite this progress, some organizations, like the European Trade Union Confederation (ETUC), argue that the new OEL still falls short of the more stringent 0.001 fibers per cm³ level recommended by the International Commission on Occupational Health (ICOH).
EU Commission Revokes Sodium Dichromate Authorization:
- In another regulatory development, the European Commission has withdrawn an authorization for Gruppo Colle to use sodium dichromate in wool dyeing. This decision follows a review that identified available alternatives to the substance, which is classified as a Substance of Very High Concern (SVHC) due to its carcinogenic nature.
- The Commission’s action aligns with the European Chemicals Agency’s (ECHA) socio-economic assessment committee’s (SEAC) findings, which highlighted deficiencies in Gruppo Colle’s substitution plan. The authorization’s withdrawal is part of the EU’s ongoing scrutiny of SVHCs, particularly chromium VI compounds, and follows a trend of moving from authorization to restriction to minimize the use of hazardous substances.
Cosmetic Safety Limits for Methyl Salicylate in Children’s Products:
- Lastly, the European Commission’s Scientific Committee on Consumer Safety (SCCS) has confirmed concentration limits for methyl salicylate in cosmetics for children. The final opinion sets specific maximum concentrations for various products, such as shower gels, shampoos, and creams, for children aged six months to three years. Methyl salicylate, commonly used for fragrance and flavoring, is restricted due to its classification as reprotoxic.
- These regulatory updates reflect the EU’s commitment to safeguarding public health and the environment by tightening controls on hazardous substances and ensuring safer working conditions across the Union.