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The regulation of cosmetic products is essential to ensure consumer safety and promote a sustainable and responsible industry. This regulation is enforced by government agencies in different countries, including the United States, the United Kingdom, and the European Union.

In the European Union, the regulation of cosmetic products is governed by the European Commission’s Directorate-General for Health and Food Safety. The EU has a strict list of prohibited substances, including those that may be harmful to human health or the environment. The EU also restricts the use of certain ingredients and requires that animal testing for cosmetic purposes be banned.

In the United Kingdom, The UK’s departure from the EU was finalized on January 31, 2020. After Brexit Enforcement, cosmetics businesses must adhere to the UK Cosmetics Regulation, also known as “The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019, Schedule 34.”  To sell cosmetic products in the UK, a company must have a Responsible Person based in the UK and comply with the following requirements.

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In the United States, the regulation of cosmetic products is overseen by the Food and Drug Administration (FDA). The FDA requires cosmetic manufacturers to ensure that their products are safe and properly labeled before they are marketed to the public. The FDA’s regulatory oversight includes the prohibition of harmful ingredients and requirements for good manufacturing practices, as well as safety testing and accurate labeling of cosmetic products.

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It’s important to stay updated on changes in cosmetic regulations as they vary from country to country. New regulations or changes to existing ones can impact product formulation, labeling requirements, and marketing claims. Staying updated can ensure that companies comply with the latest regulations and avoid any legal issues.

Influentive offers a comprehensive range of services for cosmetic regulation includes regulatory consulting, product formulation, labeling compliance, and safety testing. With our team of experts constantly monitoring the latest regulatory changes, we can help companies comply with the latest regulations in the EU, UK, and USA.

Contact us now for a professional consultation.

ADD TEXT: Overview EU Cosmetic regulation, 1223/2009, step for registration (bullet point)

ADD TEXT: Overview UK Cosmetic regulation, BREXIT, step for registration (bullet point)

Exporting to EU

The cosmetics market in the European Union (EU) is one of the largest and most developed in the world. According to data from the European Cosmetics Association (Cosmetics Europe), the EU’s cosmetics market was valued at  €80 billion at retail sales price in 2021, making it the largest cosmetics market in the world. The European Union (EU) Cosmetic Regulation 1223/2009 establishes the regulatory framework for the manufacture, import, and sale of cosmetic products within the EU. Here are the general 5 steps for registration of cosmetic products under this regulation:

Step 1: Formula Review

The formula review is a meticulous process that ensures the safety and regulatory compliance of a cosmetic product, including the establishment of the INCI list and confirmation of mandatory lab tests, before the preparation of CPSR and verification of product label.

Step 2: Cosmetic Product Safety Report (CPSR) (link to CPSR)

The CPSR (Cosmetic Product Safety Report) is a comprehensive document produced by a qualified toxicologist that includes two distinct sections, Part A containing all data needed for the evaluation of the cosmetic product and Part B providing an assessment of the product’s safety and conclusions, which is essential to certify the effectiveness and safety of a product before it can be placed on the EU market.

Step 3: Product Information File (PIF) and CPNP Notification

A Product Information File (PIF) is a complete regulatory dossier that includes the formula, CPSR A&B, and labels of a cosmetic product, and once completed, the product can be notified in the EU via the CPNP (Cosmetic Product Notification Portal) to obtain a unique CPNP number, and while the EU does not require pre-approval of cosmetic products, the selection of a competent Responsible Person is crucial for post-launch verification by competent authorities.

Step 4: Labels and Claims Review

Complying with EU cosmetic labelling rules can be confusing and costly for cosmetic brand owners, as certain elements may need to be translated into different languages depending on the country, and distributors have the right to refuse non-compliant products, making a Label Review by a recognized and experienced company like Influentive  is essential for ensuring clear and compliant labels that are easily accessible, readable, and understandable by consumers at the time of purchase.

Step 5: Responsible Person

The Responsible Person is the legal representative for cosmetic products in Europe and is responsible for ensuring compliance with EU regulations, as well as being the contact point for authorities and consumers in case of issues or concerns regarding the product.

UK Cosmetics Regulatory Compliance | Biorius

Exporting to UK

The global cosmetic products market values the United Kingdom as an important player, with retail sales valued at €9.9 billion in 2021. In Western Europe, the UK ranks third among the leading cosmetic markets, following Germany and France, and preceding Italy. It is also the world’s eighth-largest cosmetic industry, trailing behind the USA, China, Japan, India, Brazil, Germany, and France. Industry projections indicate a 25% growth rate for the global cosmetics market by 2027, with the UK predicted to experience the most substantial expansion in Western Europe in the coming years.

Step 1: Formula Review:

The focus is on ensuring regulatory and safety compliance of ingredients (INCI) in cosmetic products. This involves a thorough examination of the composition and raw materials documentation to ensure safety for the intended use and target population. The creation of a CPSR and verification of the product label are dependent on this step.

Step 2: Cosmetic Product Safety Report (CPSR)

The Cosmetic Product Safety Report (CPSR) is a crucial and complex document required by UK Cosmetics Regulation. It confirms the safe use of a cosmetic product and is produced by a qualified toxicologist who considers various information. CPSR has two sections, Part A for product evaluation and Part B for assessing safety and effectiveness. It must be signed by recognized UK and EU toxicologists and failure to provide a high-quality CPSR can result in penalties and harm to the brand’s reputation.

Step 3: A Product Information File (PIF) and SCPN Notification

The PIF is a detailed dossier with all necessary information about a cosmetic product. It must be completed and notified on the SCPN before sale in the UK. After Brexit, PIFs must be updated with names and addresses of EU and UK Responsible Persons for products sold in both territories. All cosmetic products must be re-notified in the new SCPN system for sale in the UK, and all existing products had to be re-notified within 90 days from March 31st, 2021.

Step 4: Labels and Claims review

UK cosmetic labels must comply with regulations, and a Label Review by a regulatory expert can ensure compliance, including the inclusion of country of origin and UK Responsible Person’s contact details.

Step5: Responsible Person

The UK requires a local Responsible Person for cosmetic products sold there, and brands selling in both the UK and EU need a Responsible Person in each area. The Responsible Person ensures ongoing compliance and is accountable in case of non-compliance. It’s best to find a Responsible Person with offices in both regions to represent products, and Influentive offers services in both areas.

FDA and State Regulations

Cosmetic products in the US are regulated by the FDA through the FD&C Act and FPLA, as well as state and local laws. The primary reason for FDA sanctions is label mistakes. To sell their products in the US, companies typically prioritize compliance with FDA regulations, particularly with respect to labeling and product information.

The process for selling cosmetics in the United States:

• Check and review the product ingredients in accordance with the restricted drugs list.
• Review and ensure the label conforms with the FDA requirement.
• Adapt the claims of the product to stay within the definition of designs, claims related to medicines or over-the-counter products should be avoided.
• Advisable to register the company and the products in the Voluntary Cosmetic Product Registration (VCRP) (link to FDA)

At Influentive, our experts help you to obtain 100% FDA compliance products and enter the US Market successfully!

FDA (cosmereg.com)

Modernization of Cosmetics Regulation Act of 2022 (MoCRA) SERVICES

By the end of 2023, the Modernization of Cosmetics Regulation Act (MoCRA) will become effective and it will introduce some of the most significant and transformative cosmetic regulations by the FDA.

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REF:USA Modernization of Cosmetic Regulation Act (MoCRA) • Biorius

REF :Modernization of Cosmetics Regulation Act of 2022 | FDA

SUB: MoCRA

Background Modernization of Cosmetics Regulation Act of 2022 (MoCRA)

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) represents a substantial enhancement of the FDA’s regulatory power over cosmetic products, marking the most significant expansion since the enactment of the Federal Food, Drug, and Cosmetic (FD&C) Act in 1938. This legislation is instrumental in ensuring the safety of the cosmetic products commonly utilized by American consumers.

MoCRA introduces enhanced authorities to the FDA, notably:

• Records Access: Subject to meeting specified conditions, the FDA is empowered to obtain and duplicate specific records associated with a cosmetic product, encompassing safety records.
• Mandatory Recall Authority: In cases where the FDA determines that a cosmetic product is adulterated or misbranded, posing a significant risk of severe adverse health consequences or fatality through its usage or exposure, the FDA has the jurisdiction to issue a mandatory recall if the Responsible Person declines to initiate a voluntary recall.

Significant changes of implementing USA MoCRA:

1. Responsible Person for cosmetics

Responsible Person is the new requirement and this refers to the manufacturer, packer, or distributor of a cosmetic product whose name is displayed on the product’s label.

The USA Responsible Person responsibilities including:

1. Maintaining Safety Records: Manufacturers must ensure and keep records supporting the safety of their cosmetic products. These records must be made available to authorities if necessary.
2. Adverse Reaction Management: Manufacturers should receive and handle adverse reactions associated with their products to the FDA within 15 business days. They also need to provide additional information within one year.
3. Cosmetovigilance Dossier: Manufacturers are required to maintain an updated cosmetovigilance dossier, which contains relevant information regarding the safety of their products.
4. Fragrance Component Consultation: Manufacturers must allow authorities to access the components of the fragrance used in their products if requested.
5. Product Notification: Manufacturers must notify the FDA about their products and ensure that the notification is kept up to date.
6. Allergen Labeling: Manufacturers need to correctly label allergens on the packaging of their products.
7. Market Recall Management: Manufacturers should organize a product recall when necessary or as requested by the FD

2. Implications on cosmetic ingredients and finished products

The upcoming publication of an official method for detecting asbestos in talc-containing products and the evaluation of perfluoroalkyl and polyfluoroalkyl substances (PFAS) in cosmetic products are key impacts of the USA cosmetics reform. Additionally, the reform introduces the requirement to comply with Good Manufacturing Practices (GMPs), with specific GMP requirements to be published by the FDA within three years. Another significant aspect is the emphasis on safety substantiation, where Responsible Persons must maintain records supporting the adequate justification of safety. INFLUENTIVE experts possess the expertise to conduct a thorough TRA (Toxological Risk Assessment), a review of ingredients and finished products, enabling them to determine the necessary warnings for inclusion on cosmetic labels.

3. Mandatory Cosmetic Registration

Starting from December 29, 2023, every company and cosmetic product intending to enter the USA market must register with the FDA. The previous Voluntary Cosmetic Registration Portal (VCRP) has been discontinued, and no new notifications or requests will be processed. The FDA will archive the data from VCRP without automatic migration to the new system. The MoCRA’s mandatory cosmetics registration will now take place through a new portal that enables the registration of establishments and products. The implementation of both systems will occur simultaneously.

4. Registration of company and product listing

The USA Modernization of Cosmetic Regulation Act (MoCRA) introduces two key obligations. First, manufacturers and processors must register their facilities with the FDA, renewing the registration every two years. Second, manufacturers must provide a product listing to the FDA, including details such as the product’s name, type, and ingredients, which should be updated annually. The Act also empowers the FDA to suspend facility registrations in cases where products pose a serious risk. These measures aim to enhance oversight and safety in the cosmetic industry.

• Suspension of Facility Registration: The FDA can suspend a facility’s registration if its products pose a risk of serious harm. It becomes prohibited to distribute or sell products from a suspended facility.

5. Cosmetics labeling requirements

The USA Modernization of Cosmetic Regulation Act introduces new labeling requirements for cosmetic products. In addition to existing obligations, products must now include the following mandatory information on their labels:

• Contact details: The label should provide contact information for the Responsible Person, including the possibility of a website to report adverse reactions.
• Professional use statement: If a cosmetic product is intended exclusively for use by licensed professionals, the label must clearly and prominently state this fact.
• Allergen disclosure: A list of ingredients, including labeled allergens, must be displayed on the packaging. The specific list of allergens to be labeled will be established through regulations.

These labeling provisions aim to enhance consumer safety and provide necessary information for users of cosmetic products.

Partnering with Influentive

With 17 years of experience as a cosmetics regulatory expert, INFLUENTIVE offers invaluable support to help your brand successfully sell cosmetics in the USA. Our services encompass a comprehensive compliance check of your formulas and labels, ensuring adherence to both state and federal regulations. Additionally, we conduct thorough safety assessments to guarantee the safety of your products.

Furthermore, our team of experts is well-equipped to provide you with all the necessary information regarding the Publication of the USA Modernization of Cosmetic Regulation Act (MoCRA). As regulatory changes may occur at different times, we can guide you through the next steps and inform you about the various compliance deadlines related to new Good Manufacturing Practices (GMP), labeling requirements, and safety substantiation, such as the publication of the PFAS Report on the FDA website.

You can rely on our extensive expertise to navigate the complex regulatory landscape, ensuring your products meet the necessary standards for successful market entry and compliance in the USA.

EU RESPONSIBLE PERSON

The European Regulation 1223/2009 lays down the requirements for compliance that cosmetic products must meet in order to be sold in Europe. One of the obligations for companies marketing cosmetic products is to appoint a qualified Responsible Person within the EU to ensure adherence to regulations and product safety for public health.

The Responsible Person’s duties include:

• Ensuring compliance with ingredient, labeling, and claims requirements. Establishing and maintaining the Cosmetic Product Information File (PIF).add link
• Creating the Cosmetic Product Safety Report (CPSR).
• Submitting product notifications to the CPNP portal.
• Conducting post-market surveillance.
• Reviewing nanomaterials and substances classified as CMR.

At Influentive, we provide professional services to our clients, enabling them to sell their cosmetic products in the European Union with full regulatory compliance and assurance.

UK RESPONSIBLE PERSON

The UK Cosmetics Regulation, which came into force on January 1, 2021, sets out the requirements for cosmetic products placed on the UK market after Brexit.

A cosmetics brand selling both in the EU and in the UK needs a local Responsible Person for each economic area. A Responsible Person (RP) based in the UK is required for cosmetic products sold in the United Kingdom.

The Responsible Person’s duties include:

• Create Product Information File (PIF) for each cosmetic product, reviewing ingredients and labeling of the cosmetic product to ensure compliance with UK regulations.
• Ensure that the cosmetic product complies with national policies on waste management and disposal.
• Notifying the cosmetic product in the SCPN system
• Acting as a Representative (Responsible Person) and visible in the product labeling for the cosmetic product.
• Reviewing and approving product safety and technical data, including the safety assessment, before the cosmetic product is placed on the UK market.
• Conducting market surveillance once it is on the market to ensure that it continues to comply with UK Cosmetics regulations.
• Reporting undesirable effects (SUE’s) associated with the cosmetic product to the Office for Product Safety and Standards (OPSS).

If you are interested in exporting your cosmetic products to the United Kingdom and expanding your business in this lucrative market, we can provide professional consultation and help you to attain your goals.

Prior to Brexit, the UK was part of the EU and cosmetics companies were able to use the EU’s Cosmetic Product Notification Portal (CPNP) to register their products for sale in the UK market. However, since Brexit, companies that wish to sell cosmetic products in the UK must now register their products through the UK SCPN portal instead of the EU’s CPNP.

The process for registering cosmetics through the UK SCPN portal is similar to the process for registering through the EU’s CPNP. Companies are required to submit information such as the product name, the responsible person’s name and address, the product’s composition, labeling, and function, and any specific warnings or precautions. This information is then reviewed by the UK authorities to ensure that the product complies with UK cosmetic regulations before it can be placed on the UK market.

For the EU, the registration process is still through the EU’s CPNP, and the information is reviewed by the relevant EU authorities to ensure compliance with EU cosmetic regulations. It is important to note that the regulations for cosmetics in the EU and UK have diverged since Brexit, so companies may need to comply with different regulations and requirements for each jurisdiction.

The Product Information File (PIF) is a key document required under EU and UK cosmetics regulations. It is a detailed document that provides information about the cosmetic product and its safety assessment. The PIF serves as a central repository of information related to the cosmetic product, and is used by the Responsible Person to demonstrate compliance with EU and UK regulations.

The PIF contains a wide range of information related to the cosmetic product, including:

1. Product description: This includes a detailed description of the cosmetic product, including its intended use, formulation, and packaging.
2. Ingredients: This includes a list of all ingredients used in the product, including their concentrations and functions.
3. Manufacturing process: This includes information about the manufacturing process used to produce the product, including any quality control measures in place.
4. Safety assessment: This includes a detailed safety assessment of the product, including any potential risks associated with the product and any steps taken to mitigate those risks.
5. The Cosmetic Product Safety Report (CPSR) is a comprehensive safety assessment of a cosmetic product that is required by the European Union’s cosmetics regulation. The CPSR comprises two parts: Part A and Part B. Part A contains the product information, while Part B is the safety assessment.

6. Stability data: This includes data related to the stability of the product over time, including information about the shelf life and storage conditions required to maintain the product’s quality.
7. Labeling and packaging: This includes information about the product labeling and packaging, including any warnings or precautions required by law.

The PIF must be updated regularly to ensure that it remains up-to-date and accurate. The responsible person for the cosmetic product is responsible for creating and maintaining the PIF, and for ensuring that it contains all the necessary information required by the regulations.

Overall, the PIF is an important document that plays a crucial role in demonstrating compliance with EU and UK cosmetics regulations. It provides a detailed record of the cosmetic product and its safety assessment, and serves as a central repository of information related to the product.

Cosmetic Product Safety Report (CPSR) • Biorius

Cosmetic Product Safety Report (CPSR) also commonly referred to as ‘Safety Assessment‘.

Regulations – Global Beauty Consulting

Analysis and lab tests for Cosmetics • Biorius

At Influentive, we understand the importance of ensuring that cosmetic products are safe, effective, and meet the regulations in the EU and UK. That’s why we offer lab support services for cosmetics, collaborating with accredited laboratories to provide a comprehensive range of analysis and lab tests.

Our team of experts will guide you through the process, from the initial order to analysis of the results. We offer a variety of standard lab tests required for the EU process, as well as additional and more specific testing tailored to the needs of your product.

With our commitment to transparency, you can trust us to manage everything from shipment to the lab to the delivery of detailed results.

The tests supported by our lab includes:

1. Stability Testing

The stability test evaluates a cosmetic product’s safety and efficacy over its lifecycle. It assesses physical and chemical specifications, packaging compatibility, and determines the product’s shelf life. Compatibility tests are done on the final packaging. The product is analyzed for three months under various conditions to detect interactions with the container.

2. Microbiological tests

Microbiological tests, such as challenge tests and water activity tests, are used to evaluate the potential for microbial contamination in a cosmetic product. These tests may involve exposing the product to a range of microorganisms to evaluate its resistance to contamination.

3. Preservative Efficacy Testing

Challenge testing is a type of microbiological analysis that assesses the ability of a product’s preservative system to prevent the growth of harmful microorganisms over time. It involves inoculating the product with microorganisms and monitoring their growth under various conditions to evaluate the effectiveness of the preservative system. Challenge testing is important for ensuring cosmetic product safety and preventing harmful contaminants that could cause adverse health effects in users.

4. Tolerability tests

Tolerability tests are used to evaluate the potential for skin irritation or allergic reactions to a cosmetic product. These tests may include patch testing, which involves applying a small amount of the product to the skin to evaluate the potential for irritation or allergic reaction.

5. Efficacy tests

Efficacy tests are used to evaluate the effectiveness of a cosmetic product in achieving its intended purpose. These tests may include consumer use studies, which involve having a group of consumers use the product and report on their experiences.

6. Toxicology assessments

Toxicology assessments are used to evaluate the potential for toxicity or other harmful effects associated with a cosmetic product. These assessments may involve evaluating the ingredients used in the product and their potential for harmful effects on human health.