EU CLP New Hazard Classes Published
Regulation (EU) 2023/707 amending the EU Classification, Labelling and Packaging Regulation (CLP) to introduce new hazard classes will enter into force on 20 April 2023.
The CLP aligns classification, labelling and packaging of chemicals and mixtures to the Globally Harmonised System. The CLP determines whether a chemical displays properties that lead to a hazardous classification. Once a chemical is classified, identified hazards must be clearly and uniformly communicated to other actors in the supply chain to ensure a high level of protection to human health and the environment.
The new hazard classes introduced include:
- Endocrine disruptors
- PBT (persistent, bioaccumulative, toxic) and vPvB (very persistent, very bioaccumulative)
- PMT (persistent, mobile, toxic) and vPvM (very persistent, very mobile):
Manufacturers, importers and downstream users of chemicals, or substances and mixtures, must identify relevant information to determine whether the substance entails a physical, health or environmental hazard. The information should relate to the forms or physical states in which the substance or mixture is placed on the market or reasonably expected to be used.
All substances currently on the market must be classified by 1 May 2025. However substances placed on the market before 1 May 2025 do not require classification until 1 November 2026.
All mixtures currently on the market must be classified by 1 May 2026. However, mixtures placed on the market before 1 May 2026 do not require classification until 1 May 2028.
Brazil Considers New Labelling and Packaging Requirements
Brazil's health regulatory agency (Anvisa) has proposed an update of the technical requirements for the labelling and packaging of personal hygiene products, cosmetics and perfumes.
The Collegiate Directive Resolution - RDC 752/2022 regulates personal hygiene products, cosmetics and perfumes in Brazil. The resolution defines and classifies the technical requirements for labelling and packaging and the parameters for microbiological control.
The proposed changes will bring the Resolution in line with the Mercosur standards by establishing a mandatory minimum criteria for the labelling of personal hygiene products, cosmetics and perfumes.
The objective of the agency's proposed changes is to ensure the consumer has access to clear and updated information about the characteristics of the product, including its safety, method of use and effectiveness.
EU Extended One-generation Reproductive Study Report Released
The focus of this study was to evaluate the performance of the extended one-generation reproductive toxicity study (EOGRTS) under REACH.
The aim of an extended one-generation reproductive toxicity study, or EOGRT, is to determine the potential effects of a substance on fertility, reproductive function and development.
The study evaluated the design, conduct, analysis and reporting of EGORTS. The main findings highlighted issues relating to:
- Identifying effect levels and reproductive toxicants/endocrine disruptors.
- Selecting adequate dose levels.
- Proficiency in conducting investigations
The report found, whilst EOGRTS were found to be generally effective in identifying substances of concern, some methodological issues were identified which proved "particularly challenging in terms of test laboratory proficiency".
The report recommended sponsors to improve the design, conduct, analysis and reporting of further EOGRTS.
Canada Consults on Fragrance Labelling Regulations
Health Canada has launched a consultation on its proposal to mandate the disclosure of fragrance-based allergens on cosmetic labels.
At present, Canada's Cosmetic Regulation allows the use of the generic term 'parfum'. There is currently no requirement to list fragrance ingredients individually. The proposed changes would require the disclosure of all fragrance allergens present in the cosmetic, on either the label or the brand's website depending on the size of the product.
Consultation is open to the industry, stakeholders, consumers and the public until 22 April 2023.
European Commission Publishes Report on REACH Essential Use Concept
The report aimed to assist the European Commission in the development and operation of an essential-use concept in EU chemical regulation.
The "essential-use concept" was first introduced to phase out the use of ozone-depleting chloroflurocarbons,except for certain "essential" uses. Since, the concept has been used as a tool to phase out the use of per- and polyfluoroalkyl substances (PFAS). Th
In the Chemical Strategy for Sustainability Towards a Toxic-Free Environment (CSS), the European Commission sets out a commitment to
"define criteria for essential uses to ensure that the most harmful chemicals are only allowed if their use is necessary for health, safety or is critical for the functioning of society and if there are no alternatives that are acceptable from the standpoint of environment and health."
This commitment forms the basis for the development of an essential use concept to allow for systematic decision-making in regards to the phasing out of the most harmful chemicals.
The report notes, the "complex and slow restrictions processes and heavy authorisation procedures under REACH" are major challenges in chemical regulation. The limitations delay decisions and actions to adopt appropriate risk management measures.
The report argues the implementation of the essential use concept in REACH will bring more simplicity, transparency, predictability and efficiency in authorisation decisions and derogations from restrictions by changing the approach for justifying exemptions and granting authorisations.
Key findings and conclusions:
- The essential-use concept should only apply to the uses of the most harmful chemicals which are a priority for phasing out.
- The criteria for essential-use should be retained as set out in the CSS
The CSS defines use of a substance as 'essential' for society where the use is:
1) Necessary for health, safety and/or critical functioning of society, and
2) There are no alternatives that are acceptable from the standpoint of environment and health.
- Horizontal guidance should bring further definition and consistency in application of these criteria across chemical legislation.
- Legislation-specific guidance should be developed as required.
Vermont Considers PFAS Ban
Vermont's Senate has given final approval to a bill that purports to ban manufacturers and suppliers from selling or distributing cosmetics or feminine hygiene products containing PFAS.
Per- and polyfluoroalkyl substances or PFAS are a large complex group of synthetic chemicals used in consumer products. The substances are extremely persistent in the environment and body. Multiple health effects associated with PFAS exposure have been identified and supported by a number of scientific studies.
The US Environmental Protection Agency has warned PFAS have been linked to cancer, developmental delays and organ damage.
California, Colorado and Maryland have already passed prohibitions on the use of PFAS in cosmetics, due to become law in 2025.
