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On September 15, 2022, the European Commission notified the regulatory draft on the labelling of fragrance allergens in cosmetic products. This new regulation will modify annex III of Regulation 1223/2009 on cosmetic products, adding additional fragrance ingredients subject to labelling and modifying some of those already regulated in said annex. The list of mandatory declaration allergens will go from 25 to a total of 81. It will also be necessary to update certain existing allergen entries in Annex III of Regulation CE 1223/2009, aligning the common names of the substances with those of the latest version of the Glossary of Common Ingredients referred to in article 33 of said Regulation, and grouping similar substances in a single entry. The adoption of this regulatory draft is scheduled for the Products that do not comply with the new labelling requirements cannot be placed on the market after 3 years from their entry into force. They will not be able to sell cosmetic products that do not comply with the new labelling requirements after 5 years from the entry into force. You can consult the draft of the future list of new allergens at the following link: Draft list of new allergens

On May 28, the Official Regulation (EU) 2021/849 was published which modifies the classification of Methyl Salicylate as a CMR substance (Repr.2). Due to this reason, the use of Methyl Salicylate has been restricted again in Annex III. The entry into force of the new restrictions will be on December 17, 2022. From this date, products that do not comply with the new conditions of use cannot be placed on the market or marketed. THERE WILL BE NO TRANSITIONAL PERIODS. NEW CONDITIONS OF USE OF METHYL SALICYLATE: a. Leave-on skin products (except facial makeup, spray body lotion, spray deodorant and hydroalcoholic fragrances) and leave-on hair products (except spray products). Maximum concentration: 0.06% c. Facial makeup (except lip products, eye makeup and makeup remover). Maximum concentration: 0.05% d. Eye makeup and makeup remover. Maximum concentration: 0.002% e. Leave-on hair products (aerosol). Maximum concentration: 0.009% f. Deodorant spray. Maximum concentration: 0.003% g. Spray body lotion. Maximum concentration: 0.04% h. Skin lightening products (except for hand washing) and hair lightening products. Maximum concentration: 0.06% i. Hand washing. Maximum concentration: 0.6% j. Hydroalcoholic fragrances. Maximum concentration: 0.6% k. lip products. Maximum concentration: 0.03% l. Toothpaste. Maximum concentration: 2.52% m. Mouthwash intended for children between 6 and 10 years old. Maximum oncentration: 0.1% n. Mouthwash intended for children over 10 years and adults. Maximum concentration: 0.6% o. mouth spray Maximum concentration: 0.65% In addition, its use in products for children under 6 years of age is prohibited, except in oothpastes whose maximum concentration of use will be 2.52%.

The “AGEC”, Loi relative à la lutte contre le gaspillage et à l’économie circulaire, Loi nª2020-105, was published in the French Journal Officiel on February 10th, 2020. Its objective is to act in favour of the environment through various measures. What are these measures and how they concern us? These measures are ONLY applicable on French territory. So that, companies interested to export and market their cosmetics to this country must adapt their labelling as follows: 1) Inform the consumers about the presence of dangerous substances in the product. These substances are included in the list of SVHC substances (Substances of Very High Concern) and of Substances that present a level of concern comparable to substances of extremely concern. Among them we can find Resorcitol or Bisphenol-B. 2) Inform the consumer about the presence of endocrine disruptors. According to European regulations, the presence of endocrine disruptors is banned in cosmetic products. However, the French Ministry of the Environment may include on these list substances suspected of being endocrine disruptors that are not officially considered as such. 3) Inform the consumers about the incorporation of recycled material, compostability, use of renewable resources, durability and repairs and reuse possibilities. 4) Prohibition of certain environmental claims such as "biodegradable", "environmentally friendly" and special conditions to the composting of containers. Obligation to include the percentage of recycled material in each container. 5) Specific recommendations for pregnant women, especially regarding the presence of substances of an endocrine disruptive nature. 6) Triman marking: obligation to include the TRIMAN recycling symbology physically on the packaging of the sales unit. Failure to comply with these obligations will be sanctioned with a penalty of up to €15,000 for companies from January 2023. At BELAB SERVICES we have highly qualified professionals trained in this regulation to help companies to adapt their packaging and labelling for the French market. Do not hesitate to contact us!

When a cosmetic product is placed on the European or the UK market, the party responsible for the product – known as the Responsible Person – must prepare a Product Information File (PIF) that will be accessible to competent authorities in paper or electronic format. According to Regulation (EC) No. 1223/2009, the PIF shall be kept for 10 years following the date on which the last batch of the cosmetic product was placed on the market. The product information file is a mandatory cosmetic product dossier containing all the most important information about the finished product regarded to ingredients, manufacturing process and product labelling, which shows the product characteristics, its safety and efficacy. According to the EU Cosmetics Regulation 1223/2009 and the UK cosmetics regulations, the Responsible Person must keep a product information file for each cosmetic product placed on the EU/UK market, at the address specified on the product label, readily accessible for the competent authority of the EU member state (or UK) where the responsible person is established. The product information file has to be available in a language easily understood by the local competent authority of the country where the responsible person is keeping the cosmetics product information file. PIF SECTIONS The product information file must contain the following information and data. A description of the cosmetic product Cosmetic product safety report (CPSR): - Part A: Cosmetic product safety information Quantitative and qualitative composition of the cosmetic product Physical/chemical characteristics and stability of the cosmetic product Microbiological quality Impurities, traces, information about the packaging material Normal and reasonably foreseeable use Exposure to the cosmetic product Exposure to the substances Toxicological profile of the substances Undesirable effects and serious undesirable effects Information on the cosmetic product Part B: Cosmetic product safety assessment Assessment conclusion Labelled warnings and instructions for use Reasoning Assessor’s credentials and approval A description of the method of manufacturing and either a good manufacturing practice certificate or a statement on compliance with good manufacturing practice (the GMP standard which must be followed in the EU is standard ISO 22716) Where justified, a proof of the effect claimed for the cosmetic product Any data on animal testing The product information file should also contain product labelling PRODUCT CPNP and SCPN REGISTRATION A complete cosmetics product information file (PIF) is the basis for the notification to the EU CPNP portal or the UK SCPN database, which must be performed before the cosmetic products can be placed on the EU/UK market. OUR SERVICES BELAB SERVICES LTD can offer a complete PIF and CPSR preparation service. We can offer consultancy on: the product information file content, reviewing or compiling the cosmetics product information file, preparing the cosmetic product safety assessment, checking the product labelling, performing stability and compatibility tests, challenge testing and helping you prove the effects claimed for your cosmetic products. After that we will be able to register your products in the CPNP and/or the SCPN database acting as your Responsible Person in Europe and the UK. For more information please, contact us!

In order mitigate the effects of the Russian invasion in Ukraine and help the cosmetic sector, we offer our export services totally free to cosmetic companies based in the country. Against the dramatic situation that Ukraine is experiencing after Russia's aggression, we have decided to do our part and to contribute to the country's economic recovery, especially in the cosmetic sector. For this reason, we addressed the National Association of Perfumery and Cosmetics of Ukraine (APCU) last March, which brings together all the cosmetic companies in the country, to offer all its associates our export regulatory services during 2022 and 2023 for free. With this action we hope to contribute to the maintenance and recovery of the country through our work, the best thing we know to do. If you are or know of interested Ukrainian companies, even though they are not APCU memberships, please contact us. Hope for peace. Sincerely, Daniel Jiménez CEO You can see the original APCU message below:

The US is a very attractive market for the sale and export of cosmetic products. Big (and increasingly small) companies have aroused their interest in this market with more than 300M of potential consumers. However, some products that in Europe are considered as a cosmetics are considered drugs in the US under the Federal Drug Administration (FDA) rules. Among these drugs, those with a low risk to the user health are considered OTC (Over the Counter Drugs) and can be sold without any prescription. It is the case of sunscreens, antiperspirants, anti-dandruff products or mouthwashes, among others products. Registering an OTC product in the USA under FDA compliance is a laborious process that requires the following steps: a. FDA company Registration and DUNS number obtentio n. b. Listing of products in the FDA. c. Authorized Registry Agent Appointment. d. Preparation of technical documentation - Drug Master File (DMF's) e. Ingredients and labels review under FDA monographs. At Belab Services we take care of the entire process efficiently and with maximum agility and professionalism to register your over-the-counter (OTC) products in the United States and act as a Authorized Representative with the FDA. For more information, do not hesitate to contact us. consult@belabservices.com www.belabservices.com

The U.S. Food and Drug Administration (FDA), which regulates cosmetics in the United States, reports through its data dashboard that over 2.3 million cosmetic line-items entered U.S. ports in 2020. However, this immense volume of cosmetic imports poses certain challenges as current regulations and resources limit what the Agency can do to effectively prevent potentially harmful cosmetics from entering U.S. distribution. FDA was only able to examine less than 1% cosmetic line-items in 2020. It is probable that, in the unexamined shipments, many non-compliant and potentially harmful products evaded enforcement and made their way to shelves. Meanwhile, domestically produced goods, which are not subject to any screening before entering the market, present a different issue. Solutions For Proactive Regulations Current FDA regulations for cosmetics are reactive, often addressing compliance issues after a product has already entered U.S. distribution. FDA can issue Warning Letters for non-compliance and refuse cosmetics in port, but the Federal Food, Drug, and Cosmetics (FD&C) Act does not give the Agency authority to order a mandatory recall of a cosmetic. Other products under FDA’s authority such as food, medical devices, and drugs are more proactively regulated. These products are subject to pre-market submissions and facility requirements that not only help the Agency prevent significantly more non-compliant products from entering the U.S., but also better enforce action against them when they do. In order to provide comparable regulations for cosmetics, the U.S. Congress has recently introduced The Personal Care Products Safety Act. This act is not the first of its kind, but similar bills like the FDA Cosmetic Safety and Modernization Act (S.2003) and the recent Safe Cosmetics and Personal Care Products Act of 2018 (H.R.6903) have not made it past Congress committees. Mandatory Registration of Cosmetic Facilities FDA requires businesses in most industries under its authority to register or report to the Agency prior to marketing their products in the United States. Under current regulations, FDA does not require cosmetic establishments to register, but allows them to do so voluntarily. The proposed bills would require facilities that manufacture, process, or (in some cases) distribute cosmetics for use in the United States to register with FDA. The Act would require facilities located outside of the United States to designate an agent physically located in the United States to communicate with FDA on the facility’s behalf. Cosmetic Ingredient Statements This new bill would require cosmetic facilities to submit a statement to FDA for each cosmetic intended to be marketed in the United States. The statement would contain, among other requirements, information on the facility manufacturing a cosmetic as well as the cosmetic’s ingredients and applicable warnings. FDA would require these statements be submitted within 60 days of marketing or reformulating the product and then annually (this is similar to a proposal under S.1113). Serious Adverse Event Reporting The Personal Care Products Safety Act would require cosmetics businesses to submit serious adverse event reports to FDA. The bill’s definition for “serious adverse events” are generally health-related events associated with the use of a cosmetic that result in or require medical intervention. It also requires annual reporting of adverse health events such as rashes. The Personal Care Products Safety Act would require the label of a cosmetic product to bear contact information for an entity located in the U.S. to receive notification of adverse events from consumers. A product not containing this information would be considered misbranded, subjecting it to detention or refusal at the U.S. border. Good Manufacturing Practices The Personal Care Products Safety Act would give FDA the authority to establish good manufacturing practices (GMPs) for cosmetics based on “current industry standards.” Ingredient Review The Personal Care Products Safety Act would also establish an annual review of cosmetic ingredients by FDA. As more resources would be allocated to evaluating cosmetics’ safety, FDA may forbid or restrict the use of certain ingredients currently used in cosmetics. Businesses using these ingredients would need to reformulate their product to remain compliant. In Conclusion While the Personal Care Product Safety Act is not yet close to being passed, the push for the above requirements is supported by congressional Democrats and Republicans, and the proposed regulations bear significant resemblance to existing requirements in other FDA-regulated industries. Based on the consistency of proposed cosmetics safety bills, it is likely that one may be enacted within the next several years. If this change is realized, industry will need to adapt and adjust to continue business in the United States. Companies that need assistance with FDA requirements can contact Belab Services, an expert FDA compliance consultant. Our Regulatory Specialists can review your labeling for compliance, register your cosmetics establishment with FDA, assist with reporting under the California Safe Cosmetics Act, and more.