EU REACH Testing Process Guide for Fragrances
Date：2025-03-07 09:47:49 Classification
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Guide to EU REACH Testing Process for Flavors
I. Core Requirements of EU REACH Regulations
REACH (Registration, Evaluation, Authorization and Restriction of Chemicals) is the EU's full life cycle regulatory regulation for chemical substances. Flavors as chemical mixtures must meet the following requirements:
1. Registration obligation: If the annual import/production volume of a single ingredient in a flavor is ≥1 ton, a registration dossier must be submitted to ECHA (European Chemicals Agency).
2. SVHC control: Ensure that it does not contain substances of high concern (SVHC list, the latest is 241 items), such as phthalates, polycyclic aromatic hydrocarbons (PAHs), etc.
3. Information transmission: Provide risk information to downstream users through safety data sheets (SDS).
II. Core Process of Flavor REACH Testing
Phase 1: Component Analysis and Pre-Assessment
1. Component Disassembly:
- Clearly identify all chemical components in the flavor (including solvents, carriers, additives), accurate to the CAS number.
- Focus on possible allergens (such as limonene, linalool) or restricted substances (such as coumarin).
2. Tonnage calculation:
- Classify according to the annual supply of a single ingredient in the EU market and determine the registration level (1-10 tons, 10-100 tons, and more than 100 tons).
Phase 2: Data collection and testing
1. Mandatory items:
- Physical and chemical properties: volatility, pH value, stability (oxidation/photodecomposition risk).
- Toxicological data: acute toxicity (LD50), skin irritation, sensitization (LLNA test).
- Ecotoxicology: biodegradability, aquatic toxicity (EC50 for algae/fish).
2. Exemptions:
- If the ingredient has been registered by other companies and a data sharing agreement has been reached, the existing data can be cited (fees are required).
Phase 3: Dossier submission and evaluation
1. Joint submission:
- Multiple manufacturers/importers of the same ingredient need to jointly submit data to reduce repeated testing (especially for bulk flavor raw materials).
2. CSR report:
- For ingredients ≥10 tons/year, a chemical safety report (CSR) needs to be prepared, including exposure scenarios and risk control measures.
Phase 4: Compliance response and update
1. SVHC dynamic monitoring:
- Check the SVHC list updated by ECHA every six months (such as the new perfluoroalkyl substance PFAS restriction in 2025).
2. Supply chain response:
- If the flavor contains SVHC and the concentration is >0.1%, a safe use guide needs to be provided to the recipient.
III. Key points for special testing of fragrances
1. Allergen labeling:
- According to the EU Cosmetics Regulation (EC 1223/2009) and IFRA standards, 26 allergens (such as geraniol and cinnamaldehyde) must be labeled when the concentration in the fragrance is ≥0.01% (elution type) or ≥0.001% (residual type).
2. Nanomaterial declaration:
- If the fragrance contains nanoparticles (such as nano flavor carriers), additional nano-characteristic toxicological data must be submitted.
3. VOCs control:
- Volatile organic compounds (such as ethanol and propylene glycol) must comply with the EU VOC emission directive (2010/75/EU).
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