EC Regulation 1223/2009 on cosmetics
EC Regulation 1223/2009 on cosmetics sets binding requirements for cosmetic products that have been made available on the market within the European Union. Manufacturers of products that fall under the category or cosmetics are required to abide by this regulation as they prepare their initial release of products and while continuing to sell said products within the Member States of the EU.
EU BANS THREE FRAGRANCE ALLERGENS USED IN COSMETIC PRODUCTS
THE EUROPEAN COMMISSION HAS PUBLISHED THE REGULATION (EU) 2017/1410, BANNING THE USE OF THREE FRAGRANCE ALLERGENS, HICC (CAS NO. 51414-25-6/ 31906-04-4), ATRANOL (CAS NO. 526-37-4) AND CHLOROATRANOL (CAS NO. 57074-21-2).
HICC is regulated in entry 79 under Annex III to Regulation (EC) No. 1223/2009. When its presence exceeds 0.001% in leave-on products, and 0.01% in rinse-off products, it must be declared in the list of ingredients. Atranol and chloroatranol are natural components of oak tree moss and tree moss extracts, they are neither restricted nor prohibited under current regulation.
European Commission first considered adopting SCCS opinion SCCS/1459/11 on June 26-27, 2012. The opinion concluded these fragrance allergens had caused the highest number of contact allergies cases in recent years. The European Commission has now updated the regulation to prohibit the use of these three fragrance allergens.
This Regulation enter into force from August 23, 2017.
|Annex II entry 1380||3- and 4-(4-Hydroxy-4-methylpentyl) cyclohex-3-ene-1-carbaldehyde (HICC)||51414-25-6/ 31906-04-4||257-187-9/ 250-863-4||Prohibited|
|Annex II entry 1381||2,6-Dihydroxy-4-methyl-benzaldehyde (atranol)||526-37-4||--||Prohibited|
|Annex II entry 1382||3-Chloro-2,6-Dihydroxy-4-methyl-benzaldehyde (chloroatranol)||57074-21-2||--||Prohibited|
TIMELINE for Compliance:
· From August 23, 2019,
only cosmetic products which comply with the Regulation shall be Placed on the European Union market.
· From August 23, 2021,
only cosmetic products which comply with the Regulation shall be made available on the European Union market.
SOURCE of Information:
- SCCS/1459/11 Opinion on Fragrance allergens in cosmetic products adopted on December 13-14, 2011
- COMMISSION REGULATION (EU) 2017/1410 of August 2, 2017 amending Annexes II and III to Regulation (EC) 1223/2009 of the European Parliament and of the Council on cosmetic products
EC Regulation 1223/2009 was created by the European Parliament and Council with the intent of establishing standards for cosmetic products that are available on the market. Compliance to these standards helps protect the functioning of the internet market, but most importantly, it provides a high-level of protection for the safety and health of EU citizens. The Regulation was set into force on July 11, 2013.
In its quest to protect the health and safety of EU citizens, EC Regulation 1223/2009 regulates a multitude of aspects related to the manufacturing and labeling of products that are considered to fall into the category of cosmetics.
Responsibility and accountability for safety
Before a cosmetic product can be released on the market, proof must be provided that it is safe for human health during the course of its intended use or what is considered to be reasonable foreseeable conditions of its use. Article 3 of EC Regulation 1223/2009 builds upon Directive 87/357/EEC guidelines regarding the safety of the product in reference to its instructions for use, its disposal and most importantly, its labeling. A safety assessment must be performed and a cosmetic product safety report provided to demonstrate compliance with Article 3. Guidelines for the report are found in the Regulations Annex I.
Under Article 4 of the Regulation, a representative of the manufacturer must be named as the “responsible person” for dealing with compliance with EC 1223/2009. This responsible person is responsible for ensuring that the manufacturer remains in compliance before and after bringing their cosmetic product to market.
In the event the cosmetic product does not meet the requirements of compliance under the Regulation, the responsible person must address those issues. If the manufacturer becomes aware that the cosmetic product presents a threat to human health, the responsible person must notify the competent authorities within each Member State where the product is available. The notification would include details of the risks of using the product, non-compliance issues and what corrective actions will be performed. Corrective actions may include withdrawing the product from the market or initiating product recalls.
Maintaining an accessible product information file
Another responsibility of the responsible person is that they must maintain a product information file for each cosmetic product that is put on the market by his or her company under Article 11 of EC 1223/2009. This file must remain accessible by the public and government for at least 10 years after the last batch of the product was placed on the market. The product information file at minimum must contain information and data regarding the description of the cosmetic product, safety reports regarding the product, and evidence that the product performs according to manufacturer claims. Additionally, data about any product testing on animals that may have been performed by the manufacturer, agents of the manufacturer or suppliers must be included in the information file.
Oversight of sampling and analysis of cosmetic products
Under Article 12 of EC 1223/2009 requires that cosmetic products must be sampled and analyzed in a reliable and reproducible manner. If local Community legislation, as what might be found in a Directive is non-existent, the assumption will be that the manufacturer will rely on methods of harmonized standards that have been published in the Official Journal of the European Union.
Obligation to supply information
The appointed responsible person must supply information to the EU Commission according to the guidelines provided under Article 13 of the Regulation before their cosmetic product can be placed on the market. This information includes the name and category of the product, contact information for the responsible person, the product’s country of origin, and Member State(s) where the product where be sold.
Labeling requirements for cosmetic products
Before placing cosmetic products on the market, the manufacturer must comply with container and packaging labeling guidelines under EC 1223/2009. To comply with the Regulation all required information must be presented in a legible and indelible manner.
Information to be included shall include:
- Name and address of the responsible person and country of origin for imported products
- Weight or volume of cosmetic product at time of packaging
- Expiration date of product when stored under appropriate conditions
- Precautions to be followed in the use of the cosmetic product
- Identifying batch number for the manufacture of the product
- Explanation of the function of the cosmetic product if its use is unclear
- Ingredients listed in descending order of the weight of each when added to the product; ingredients that are present in concentrations of less than 1% can be listed in any order after the main ingredients
Restrictions for hazardous ingredients and animal testing
Certain product ingredients are prohibited under Chapter IV of EC 1223/2009 based on their threat to human health. Annexes II through VI address what substances are prohibited and restricted, including ingredients such as colorants, preservatives and UV filters.
Chapter V addresses the prohibition of animal testing with the final formulation of cosmetic products, before being placed on the market and when testing methods are other than the alternative methods that have been validated and adopted by the EU Community.
Evolution and legal implications
As a regulation, EC No 1233/2009 supersedes previous Directives that applied to cosmetic manufacturers throughout the European Union. As of 30 November 2009, all Member States are required to adhere to the guidelines for compliance to this regulation. Regulations carry more legal weight than Directives, which generally provide guidance in good practices that should be followed by individual Member States.
In the event of non-compliance, the relevant competent authority will inform the competent authority of the responsible person’s Member State. When there are grounds for concern or certainty exists that the cosmetic product presents a serious risk to human health, the authority will take steps toward instituting appropriate provisional measures to withdraw, recall or restrict the availability of the non-complying product.
- Turner, Dawn M. "Understanding EC Regulation 1223/2009 on cosmetics". Desjardin. Retrieved 19 December 2016.
- "REGULATION (EC) No 1223/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 30 November 2009 on cosmetic products". Official Journal of the European Union. Retrieved 19 December 2016.
- "Safer cosmetics for Europeans". EUR-Lex. Retrieved 19 December 2016.
- Mildau, G.; Huber, B. "The New EC Cosmetics Regulation 1223/2009 – Contents and First Explanations" (PDF). International Journal for Applied Science - Personal Care - Detergents - Specialties. Retrieved 19 December 2016.
- "On cosmetic products" (PDF). Center for Sustainability and Commerce, Duke University. Retrieved 19 December 2016.
- Cosper, Alex. "What you should know when packaging cosmetics compliant to EU regulations". Desjardin. Retrieved 19 December 2016.