FDA Issues Draft Guidance for for Registration and Listing of Cosmetic Product Facilities and Products
The FDA has issued a draft guidance for the cosmetic facility registration and product listing requirements established under MoCRA.. The guidance outlines MoCRA requirements, exemptions for certain small businesses, and the importance of accuracy. Existing cosmetic facilities and products must be submitted by December 29, with updates to registrations and listings as changes occur. The new electronic registration and listing submission portal will be available in October 2023.
To ensure compliance and proper registration of manufacturing facilities and product listings, cosmetic businesses are required to follow these steps:
Facility Registration:
- Eligibility: Businesses with an average gross annual sales of less than 1 million for the past 3 years, not producing products that contact mucus membrane, are injected, intended for internal use, or alter appearance for over 24 hours are exempt.
- Declaration of Accuracy: Persons registering must provide a declaration affirming the accuracy and truthfulness of the information provided.
- Facility Operator: The owner or operator of the facility is responsible for registration. If a facility manufactures for another entity, a single registration suffices, even if multiple products are manufactured.
- Timeline: If your facility was operational before December 29, 2022, register by December 29, 2023. For those beginning operations after, register within 60 days of initial engagement by February 27, 2024.
- Renewal: Renew registration every two years.
- Required Information: Submit owner/operator's name, facility name, physical address, email, and phone number. For foreign facilities, provide the US agent's contact details if applicable. Include the FDA Establishment Identifier (FEI number) if available. List all brand names under which cosmetic products are sold, product categories, responsible person, and submission type.
- Additional Optional Information: Parent company name (if applicable), Facility DUNS Number, and additional contact information.
Product Listing:
- Responsible Person: The entity responsible for listing products, e.g., small business or products classified as both drug and cosmetic.
- Multiple Products in Single Listing: Single listings can encompass products with identical formulations or differing in colour, fragrance, flavour, or quantity. Equivalency statements may apply here.
- Listing Timeline: Products marketed on or before December 20, 2022, need to be listed by December 29, 2023. For products marketed afterward, list within 120 days of marketing.
- Required Information: Include the facility registration number where the product is processed, responsible person's name and contact number, cosmetic product name as labelled, applicable cosmetic categories, ingredient list, including fragrances, flavours, and colours, with names or common names. Provide the previous product listing number if applicable, submission type, and optional information such as parent company name, business type, label image, product web page link, and professional-use designation.
- Additional Optional Information: Responsible person DUNS Number for the listed address, unique ingredient identifiers, and further contact details if needed.
Stakeholders have the opportunity to provide feedback on the guidance until 7 September 2023.
Oregon to Implement Animal Testing Ban
On 7 August 2023 the Cruelty Free Cosmetics bill was introduced and enacted in four key states: Rhode Island, Washington, Florida, and Oregon. These new regulations have been set in motion following the conclusion of state legislative sessions across the nation.
Oregon's governor recently signed the Cruelty Free Cosmetics bill into law last week. This legislation will go into effect on 1 January, 2024, making Oregon the eleventh state in the US to embrace these regulations
Cosmetic animal testing is not outlawed at a federal level in the US. Under the Federal Food, Drug, and Cosmetic Act (FD&C Act) cosmetic products must be unadulterated and not contain any poisonous or deleterious substances, and under the Modernisation of Cosmetic Regulation Act (MoCRA) the safety of a cosmetic product must be adequately substantiated. Companies may determine animal testing is necessary to meet each of these standards, however they will now be unable to produce or sell the animal-tested cosmetics in eleven states in the US.
Where animal testing is used, the FDA advises that the testing draws the maximum amount of useful scientific information from the minimum number of animals and employs the most humane methods available.
Full list of states banning animal testing:
- New York
- Maryland
- Virginia
- Louisiana
- Hawaii
- California
- Maine
- Illinois
- Nevada
- New Jersey
UK to Modernise Product Safety Laws
The UK's Office for Product Safety and Standards (OPSS) has initiated a safety consultation aimed at modernising product safety regulations for the digital era. This comprehensive revamp, including the Cosmetics Regulation, is designed to effectively govern emerging technologies and changing shopping patterns.
The government's initiative follows the Product Safety Review's call for evidence in 2021, which sought insights into the efficacy of existing product safety legislation for consumers, businesses, and enforcement bodies.
Nico Shaw Núñez, head of internal growth and regulatory services at the Cosmetic Toiletry and Perfumery Association (CTPA) explains
"The UK Government launched a call for evidence in 2021 called the Product Safety Review, in which the OPSS was looking for information on how well the product safety legislation in general worked for consumers, businesses and enforcement authorities."
The Department for Business and Trade (DBT), under OPSS, is seeking input from consumers, businesses, and authorities to shape the consultation's direction.
The proposal's core objectives are detailed below:
- Establish a new model where businesses are subject to commensurate obligations based on their product's potential hazards.
- Create an adaptable and responsive regulatory framework that strikes a balance between regulations and industry-driven standards, stimulating the creation of innovative safe products
- establish parity between online and physical commerce, ensuring safety in both domains. This effort aims to address concerns about the safety of products sold online.
Commenting on whether these proposed changes would align the UK with EU safety regulations, Shaw Núñez states:
“The CTPA recognises the importance of the principle of autonomy now that we are a third country to the EU. However, the EU is an essential trading partner for UK cosmetics companies, and we, therefore, we need to ensure that we maintain compatibility with EU regulations and other international markets, to ensure that UK businesses can continue to trade smoothly,”.
Explaining, whilst the updates may not fully align with the EU “Compatibility allows UK companies to export to the EU and other markets without adopting the same approach.”
EU Amends Ecolabel Criteria for Cosmetic Products
On 26 July the EU published Commission Decision (EU) 2023/1540 amending the Ecolabel criteria for cosmetic products.
Commission Decision (EU) 2021/1870 established the EU Ecolabel criteria for cosmetic products and animal care products. The aim of the EU Ecolabel Scheme is to promote the use of products that have limited impacts in terms of eco-toxicity and biodegradability, contain a limited amount of hazardous substances and use less and easily recycled packaging. To ensure a harmonised application of the awarding system, this decision establishes the EU Ecolabel criteria and related assessment and verification requirements.
Under EU Decision 2021/1870, cosmetic products must comply with the following criteria to be awarded the EU Ecolabel:
- toxicity of rinse-off products to aquatic organisms;
- biodegradability of rinse-off products;
- aquatic toxicity and biodegradability of leave-on products;
- excluded and restricted substances;
- packaging;
- sustainable sourcing of palm oil, palm kernel oil and their derivatives;
- fitness for use;
- information on EU Ecolabel.
The recent amendments provide a clearer wording of these provisions.
- The definition of “active content” is revised to “Active content (AC) means the sum of organic ingoing substances in the product, expressed in grams, calculated on the basis of the complete formulation of the final product, but without the water content of the ingredients and the organic rubbing/abrasive agents”.
- Criterion 4 is revised to not include reference to impurities. Ergo, listed substances shall not be included in the product, regardless of the concentration, neither as part of the formulation, nor as part of any mixture included in the formulation.
