Cosmetics:
European Commission Continues to Reject Fragrance Industry’s Safety Assessment Method
SCCS Review on QRA Methodology: The European Commission’s Scientific Committee on Consumer Safety (SCCS) has once again rejected the fragrance industry’s Quantitative Risk Assessment (QRA) methodology for evaluating the safety of fragrance chemicals in cosmetics. Despite updates, the SCCS stated that the QRA2, an evolved version of the original QRA, still requires further refinement. This opinion marks a continuation of concerns since the methodology’s initial review in 2008.
Background of QRA Methodology: Originally developed in 2006 by the International Fragrance Association (IFRA), the QRA was designed to predict safe exposure levels to prevent skin sensitization from fragrances. Skin sensitization involves an induction phase, where initial exposure primes the immune system, and an elicitation phase, where further exposure triggers an allergic response. The SCCS first evaluated this method in 2008, concluding that it could not confidently endorse the safety levels proposed for consumers.
Ongoing Issues and Recent Developments: Despite several re-evaluations, the SCCS has consistently found the methodology lacking, citing inadequate scientific reasoning in its framework. A 2017 opinion highlighted these shortcomings, noting that it was not possible to establish a safe concentration for fragrance induction of sensitization. In their latest review of citral—a common fragrance ingredient noted for its lemon scent—the SCCS recognized improvements in the QRA2 framework but emphasized the need for more case studies to validate its efficacy.
Regulatory Implications and Future Steps: While the QRA2 has shown some progress, the SCCS will continue to assess its suitability for fragrances and other cosmetic ingredients on a case-by-case basis until more definitive evidence is provided. This cautious approach underscores ongoing uncertainties in fragrance safety assessments, affecting both product formulation and regulatory compliance.
Contrast with US Regulatory Progress: In the United States, the fragrance industry has seen more success in regulatory acceptance through collaboration with the Environmental Protection Agency (EPA). The EPA has adopted a streamlined risk assessment approach that has expedited the review of new fragrance substances under the Toxic Substances Control Act (TSCA), reflecting a more favorable regulatory environment compared to the EU’s stringent scrutiny.
REACH:
Overview of the Community Rolling Action Plan (CoRAP) for Substance Evaluation
Purpose of CoRAP: The Community Rolling Action Plan (CoRAP) is an initiative under the EU’s REACH regulation, where specific substances are selected for evaluation to assess potential risks to human health or the environment. If a substance is listed in CoRAP, it indicates that a Member State has either evaluated it or plans to do so within the next few years.
Details in the CoRAP List: For each substance on the list, the CoRAP table includes the evaluating Member State, the planned year of evaluation, and a brief description of the concerns that led to its inclusion. This information helps in tracking the progress and focus of substance evaluations across the EU.
Documentation and Evaluation Process: Accompanying documents related to the substance evaluations are accessible through the CoRAP. These include justifications for selecting substances, requests for additional information, and final evaluation reports from Member States for substances whose evaluations have been completed. The process ensures transparency and provides detailed insights into the rationale and outcomes of evaluations.
Key Definitions and Notes:
- Joint Evaluations: Some substances are jointly evaluated by two Member States, with the first mentioned state leading the evaluation.
- Substance Identification: Public names, usually as disseminated on the ECHA website, are used to identify substances. EC numbers or numbers assigned post-inquiry by ECHA are used where applicable.
- Concern Labels: Substances are categorized based on potential concerns, such as suspected persistent, bioaccumulative and toxic (PBT/vPvB), persistent mobile and toxic (PMT/vPvM), carcinogenic, mutagenic, reprotoxic (CMR), and sensitizing properties.
Outcome and Further Clarifications: The inclusion of a substance in the CoRAP is based on initial concerns which are indicative and subject to change following detailed evaluations. The evaluations may lead to regulatory actions if the concerns are confirmed. Documents provided along with the CoRAP entries explain the initial concerns and the scope of the evaluations, serving as a preliminary assessment pending the final evaluation results.
Contact Information: For each substance listed, contact details of the evaluating Member States are provided, facilitating further inquiries and ensuring accessibility to responsible authorities regarding the substance evaluation process.
This structured approach in the CoRAP allows for systematic and coordinated evaluations of substances across the EU, aligning with the goals of REACH to protect human health and the environment from potential chemical risks.
Food:
EFSA Panel Approves Oxidized Rice Bran Wax for Certain Plastic Food Contact Materials
Safety Approval for Specific Plastics: An expert panel from the European Food Safety Authority (EFSA) has determined that oxidized rice bran wax and its calcium salt are safe for use as an additive in specific plastic food contact materials (FCMs). This approval, effective as of August 5, applies to concentrations up to 0.3% by weight in polyethylene terephthalate (PET), polylactic acid (PLA), and rigid polyvinyl chloride (PVC). These materials are suitable for contact with all types of food except fatty foods, and for long-term storage at room temperature or lower.
Regulatory Context and Union List: Oxidized rice bran wax must be listed on the Union List, which catalogs substances authorized for use in plastic FCMs. Companies seeking to use additives not currently on the list must have them assessed by EFSA for safety. Following EFSA’s opinion, the European Commission may consider updating the Union List to include these substances.
Concerns for Other Plastics: While the approval extends to PET, PLA, and rigid PVC, the EFSA panel noted concerns about using oxidized rice bran wax in polyamides (PA), thermoplastic polyurethane (TPU), and plasticized PVC. These materials may exhibit higher migration rates of potentially genotoxic compounds due to their physical properties, such as increased swelling in PA in contact with aqueous foods and higher diffusivity in TPU and plasticized PVC. Consequently, the current data do not adequately address potential migration issues in these plastics.
Product Launch and Applications: Clariant Produkte GmbH, the applicant for this assessment, introduced a line of renewable rice bran wax products under the brand name Licocare RBW Vita in 2018. These products are marketed as eco-friendly alternatives to montan and synthetic waxes, with applications in engineering thermoplastics and epoxy molded components.
The EFSA’s approval marks a significant step toward broadening the safe use of sustainable materials in the food packaging industry, although further evaluations are necessary for a comprehensive safety assessment across all potential plastic applications.
CLP:
Updates on Harmonized Classification and Labeling for Chemical Substances
New Intentions for Classification and Labeling: The European authorities have received nine new intentions to harmonize the classification and labeling of various chemical substances. These include a range of products primarily consisting of different forms of rosin and its derivatives, such as:
- Rosin, maleated
- Reaction products of tall oil fatty acids with maleic anhydride
- Rosin, fumarated
- Resin acids and Rosin acids, fumarated, esters with glycerol
- Rosin, oligomers Additionally, intentions include various cobalt compounds and decan-1-ol, highlighting a focus on materials used in industrial processes and potentially in consumer goods.
Proposal Submission: A proposal has been made to harmonize the classification and labeling of 1,3,4,6,7,8-hexahydro-4,6,6,7,8,8-hexamethylindeno[5,6-c]pyran galaxolide (HHCB), a synthetic musk frequently used in fragrances. This proposal aims to standardize how this chemical is classified across the EU to ensure consistent handling and safety measures.
Withdrawal of a Previous Submission: A withdrawal notice has been received for bis(4-methylbenzoyl)peroxide, a chemical often utilized in polymer production. The reasons for this withdrawal have not been specified but indicate changes in the regulatory or commercial status of this substance.
Call for Comments on CLH Proposal: The European authorities are also opening a consultation for the harmonized classification and labeling of choline hydrogen phosphonate. Stakeholders and the public are invited to submit comments, which will help in determining the appropriate classification and safety measures for this chemical.
These developments are part of ongoing efforts to ensure that chemicals used within the EU are properly regulated to protect both public health and the environment. The classification and labeling process is crucial for providing clear hazard information and handling instructions to users across various sectors.
