Monthly Report on Chemical and Industry Regulatory Developments in the Consumer Goods Sector - December 2023

I. Core Regulatory Developments in Europe

(I) Investigation and Control Advancement of Toxic Substances in Child Care Products

On November 8, 2023, the European Chemicals Agency (ECHA) released survey results indicating that child care products such as child car safety seats, bibs, toiletry-related products, bedding, and mattresses commonly contain substances like cobalt, lead, and phthalates including di(2-ethylhexyl) phthalate (DEHP). These substances are carcinogenic, mutagenic, or toxic to reproduction (CMR). The report provides key support for the European Commission to develop proposals restricting hazardous chemicals in child care products in accordance with Article 68 of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) Regulation.

(II) Recent Key Updates to the REACH Regulation

(III) Important REACH and CLP-Related Links

1. REACH-related: Intentions to register restrictions, Intentions to register Substances of Very High Concern (SVHC), Substance Evaluation (CoRAP), Opinions on granted authorization applications and past consultations, Authorization applications (current consultations), Current calls for comments and evidence, Authorization list, Completed restriction activities by ECHA, Proposed restriction measures under consideration, Regulatory need assessment list.

2. CLP-related: Intentions to register harmonized classification and labeling (CLH), Harmonized classification and labeling consultations.

(IV) Developments in the Textiles and Leather Sector

1. New Geographical Indication Protection Regulation: On October 27, 2023, the European Commission issued Regulation (EU) 2023/2411, establishing a geographical indication protection system for artisanal and industrial products. It applies to artisanal and industrial products (excluding agricultural products, foodstuffs, or spirits) and takes effect on December 1, 2025.

2. Standard Updates:| Reference Standard | Title | Repeal Date (*) | Replacement Standard ||--------------------------|-----------------------------------------------------------------------|-----------------|--------------------------|| EN 16484:2023 | Leather - Requirements for determining the origin of leather production | March 31, 2024 | EN 16484:2015 || EN ISO 1833-4:2023 | Textiles - Quantitative chemical analysis - Part 4: Mixtures of certain protein fibres with certain other fibres (method using hypochlorite) | April 30, 2024 | EN ISO 1833-4:2017 |

(V) Other EU Chemical-Related Initiatives

II. Regulatory Developments in the United States

On November 17, 2023, the California Office of Environmental Health Hazard Assessment (OEHHA) added coal tar pitch, fluoro-edenite fibrous amphibole, and silicon carbide whiskers to the Proposition 65 list of known carcinogens. Starting from November 17, 2024, products containing these three chemicals must bear Proposition 65 warning labels. Details are as follows:

III. International Regulatory Proposal Notifications to the WTO

IV. Sustainability and Environment-Related Initiatives

(I) Publications by the European Commission

(II) Publications by the French Ministry for Ecological Transition

V. Technology and Safety Developments in the Cosmetics and Personal Care Sector

(I) Innovative Efficacy Testing Protocol

Eurofins Analytics has launched an expression line testing protocol based on C-Bright technology. Using standardized photography and custom software, it can measure invisible expression lines caused by emotions such as smiling, suitable for evaluating the efficacy of anti-aging products for the 25-40 age group.

(II) Accurate Detection of Nitrosamines

1. Risk Background: Nitrosamines are potential carcinogens, often formed unintentionally when nitrosating agents react with amine components under specific production/storage conditions. Among them, N-nitrosodiethanolamine (NDELA) is the most carcinogenic, while N-nitrosodimethylamine (NDMA), N-nitrosomorpholine (NMOR), and N-nitrosoethylamine (NDEA) are also of concern. Skin care products, hair dyes, mascaras, and nail polishes are key screening categories.

2. Regulatory Requirements: Regulation (EU) No 1223/2009 stipulates that nitrosamine content in cosmetics must be below technically unavoidable trace levels under good manufacturing practices.

3. Testing Capabilities: Eurofins Analytics uses GC-MS/MS and LC-MS/MS technologies to detect NDELA in accordance with ISO 15819:2014, and is developing a screening procedure for total nitrosamine content.

(III) Cold-Resistant Cosmetics Testing

1. Testing Scenario: Leveraging the harsh cold environment in Canada to evaluate the barrier protection and moisturizing capabilities of cold-resistant products for skin, hair, lips, and other areas.

2. Testing Methods:

• Instrumental testing: Tewameter® (measurement of transepidermal water loss) and Corneometer® (measurement of stratum corneum moisture content);

• Supplementary assessment: Expert clinical scoring, image analysis, and consumer questionnaires.

VI. Supplementary Standard Updates

Note: *Repeal date refers to the deadline by which national standards conflicting with European standards (EN/HD) must be repealed.