The Modernization of Cosmetic Regulations Act of 2022 (MoCRA) is the first major update to the US Food and Drug Administration’s (FDA) authority over cosmetic products since 1938.

By 1st July 2024, cosmetic brands and manufacturers will need to ensure that their practices comply with the new law. While the industry waits for FDA to finalise instructions and guidance, we can help brands and manufacturers prepare for this now to ensure you stay compliant when the law comes into force. Our range of services include:

• Acting as US agent
• Facilities registration
• Product listing
• FDA and state regulatory compliance checks on formulations
• Artwork checks (both State and FDA)
• Safety substantiation
• Accelerated stability studies
• Preservative efficacy (challenge) testing

More about MoCRA

The MoCRA requirements now in force from 1 July 2024 include:

• Mandatory Facility Registration: Cosmetic brands and manufacturers must register their facilities with the FDA and renew their registration every two years.
• Product Listing: A responsible person must list each marketed cosmetic product with the FDA, including product ingredients, place of manufacture, product listing number, and provide any updates annually. This registration must be complete before December 2023 for existing products on the market and 120 days for new products.
• Adverse event reporting: A responsible person is required to report serious adverse events associated with the use of cosmetic products in the US to the FDA within 15 business days after receiving the report and certain additional information, such as new medical information, within one year of the initial report. The FDA will also have access to adverse event reports during an inspection.
• Safety Substantiation: A responsible person is required to ensure and maintain records supporting adequate safety substantiation for their products.

As part of MoCRA, the FDA will also be establishing regulations for:

• Good Manufacturing Practice (GMP): This will align US GMP with international standards and is expected to be completed in 2025.
• Fragrance allergen labelling: Cosmetic labels will be required to identify every fragrance allergen in a product. This requirement will take effect at the end of 2024.
• Talc: The FDA will be issuing regulations to establish and require standardised testing methods for detecting and identifying asbestos in talc-containing cosmetic products.
• Perfluoralkyl and polyfluoralky substances (PFAs): The FDA is required to issue a public report, no later than three years after MoCRA is enacted, to assess the use of PFAs in cosmetic products.

For small businesses, there are exemptions from GMP, registration, and product listing requirements. More guidance will be issued in the coming months.

Regulatory considerations of producing bespoke cosmetics in store

In recent years, the availability of personalised cosmetic and personal care products created in-store has been growing. This trend has evolved so quickly, that there is no specific regulation for these ‘point of sale’ (POS) cosmetics – instead, multiple laws apply. What’s more, meeting the requirements of UK and EU Cosmetic Regulations, specifically Good Manufacturing Practice (GMP), is much more challenging compared to the traditional method of production in a factory.

So, to stay compliant and ensure the safety and quality of products, here’s a comprehensive guide of what to consider when creating products at the point of sale (POS).

• Labelling.

Ensure product labelling complies with Article 19 of Regulation (EC) No 1223/ 2009. In indelible, easily legible, and visible lettering, labelling should include: the name of the Responsible Person (RP), a batch code and unique batch number, nominal content, the date of minimum durability or period after opening (PAO), the product’s function, and ingredient list. The use of a loose leaflet is not accepted if there is enough space on the packaging itself.

• Preparation, cleaning, and training.

Ensure the preparation of bespoke products is completed by fully trained personnel only, in a dedicated area compliant with the requirements of GMP.  This zone must be cleaned following a predetermined and documented process (Standard Operation Process), which details the cleaning protocol, frequency, and training.  Minimise cross contamination by allowing only trained personnel access to the area.

Training must include how to prepare products to the requirements of GMP and be recorded in a guide for each employee.

• Ingredients.

Where products are made from several ingredients, are the individual components cosmetic products in their own right or chemicals? The mixing of ingredients that can be considered cosmetic products is preferential since the use of raw materials (chemicals) in bespoke products is very complex – and unlikely to be appropriate for an in-store setting. Additionally, enhanced training and documentation are also required to ensure worker safety.

• Filling, refilling, and storage.

Tightly monitor the filling of product into packaging and perform regular controls and audits to ensure quality control. Filling directly into customers’ pre-used empty containers is not recommended, due to contamination risks. However, it is acceptable to exchange a pre-used receptacle for an industrially cleaned one to refill at the POS.

Packaging used for filling should be stored to protect from contamination prior to filling. Refill batches should never be mixed, and the expiry/PAO dates must be respected.

• Safety.

The very nature of bespoke products means that many similar versions are created – and each one must be compliant. Due to the cost and impracticability of commissioning testing for every combination of ingredient, the production of microbiological high-risk products is not recommended. All possible combinations of the product must be considered during safety assessments. In certain cases, read-across data for preservative efficacy (challenge) testing and stability studies may be acceptable.

• Traceability.

Each product must contain a batch code and a traceability document should also be kept updated showing concordance between incoming refill-bulk, packaging materials, and the sold finished product. Ensure each unique combination of ingredient has an individual notification and Product Information File (PIF).

Additionally, any product returned to store must be documented and held centrally by the RP to ensure any safety-related reports, trends in the poor performance of the product or durability are identified and addressed quickly.

For further information or advice, please contact us.

Microbiology for Medical Devices

Microbiological testing is imperative to safeguard patient health. We offer a range of testing services specifically for the healthcare sector, to help prevent microbial contamination and support compliance. This includes test methods for medical devices and wound care.

Manufacturers of medical devices must ensure that their products meet the highest quality control standards. Microbiological testing is essential to ensure that a device is safe and effective, by examining the presence of harmful pathogens that could contaminate it. Furthermore, it is required to stay compliant with regulations.

We offer a range of medical device testing methods, including coating efficacy, bioburden assessment and implantable device assessment. Standard test methods include:

• ASTM D7907: Standard test methods for determination of bactericidal efficacy on the surface of medical examination gloves
• BS EN ISO 17664-1 Processing of healthcare products
• BS EN 1616: Sterile urethral catheters for single use
• ISO 22196: Measurement of antibacterial activity on plastics and other non-porous surfaces

Wound care

Most chronic wounds are a result of microbial infection. Even if they are not clinically infected, wounds are often colonised, which in itself means they are at risk of infection. Our experienced microbiological technicians can support you in evaluating wound care strategies, such as anti-microbial wound dressings and smart dressings.

Standard test methods include:

• AATCC Test Method 100: Antibacterial Finishes on Textile Materials. This test method provides a quantitative procedure for the evaluation of a product’s antibacterial activity. Assessment of an antibacterial finish on a textile material is determined by the degree of antibacterial activity intended by the use of such materials.
• AATCC 30 Antifungal Assessment and Mildew Resistance Test
• ASTM E2149: Standard Test Method for determining the antimicrobial activity of immobilized antimicrobial agents under dynamic contact conditions.
• AATCC Test Method 147: Antibacterial Activity Assessment of Textile Materials: Parallel Streak Method
• BS EN ISO 11737-1: Sterilization of Medical devices. Microbiological Methods. Determination of a population of microorganisms on products (Bioburden)
• BS EN ISO 20743: Textiles, Determination of antibacterial activity of antibacterial finished products
• BS EN IS0 20645: Textile fabrics. Determination of antibacterial activity. Agar diffusion plate test

For more information about how we can support your healthcare testing needs, please contact us.

Safety Data Sheets (SDS)

Safety Data Sheets provide information on chemical products, describing the hazards that the chemical presents, as well as giving information on handling, storage, and emergency measures in case of accident.

They are essential for chemical products; however, they require technical expertise and can be time-consuming to prepare. Furthermore, they need reviewing regularly to ensure that they meet changing regulations.

Although finished cosmetic products do not require SDS in terms of their consumer use; manufacture, storage, transportation, and retail sale hazards can arise during production. The production of SDS is an effective method commonly used to provide information required for safe use and disposal of the cosmetic product.

We can create SDS for global regulatory compliance (CLP & OSHA) in 39-languages. From receipt of data, we can usually issue your completed SDS within two weeks. We can also complete Poison Centre Notifications.

Poison Centre Notifications

Companies (such as manufacturers, importers, downstream users, and distributors) that place hazardous mixtures on the UK or EU markets must complete poison centre notifications (PCN) and submit them to the relevant authority; the National Poisons Information Service in the UK and the European Chemicals Agency (ECHA) in the EU.

These mandatory documents provide important information about mixtures classified for health or physical hazards, including emergency health response and preventative measures, and are used by poison centres when incidents or exposures occur.

We offer a full PCN service to support companies comply with poison centre obligations in the UK and EU markets. This includes unique formula identifier (UFI) code generation, dossier preparation, and submission.

Subscription Service

Our new SDS subscription service enables you to outsource the responsibility of maintaining these essential documents to our in-house specialist SDS team. The package includes alerts and notifications of upcoming changes, consultancy, an annual review to ensure they remain up to date, and a limited number of revisions, as applicable. This year-round support saves you valuable time and effort, offers reassurance that your completed SDS is technically accurate, and helps you to stay compliant with regulations that are constantly being reviewed.

Globally Harmonized System of Classification and Labelling of Chemicals

Our SDS follow the standard 16-section format and can include a company logo if required:

• Section 1. Identification
• Section 2. Hazard(s) identification
• Section 3. Composition/information on ingredients
• Section 4. First-Aid measures
• Section 5. Fire-fighting measures
• Section 6. Accidental release measures
• Section 7. Handling and storage
• Section 8. Exposure controls/personal protection
• Section 9. Physical and chemical properties
• Section 10. Stability and reactivity
• Section 11. Toxicological information
• Section 12. Ecological information
• Section 13. Disposal considerations
• Section 14. Transport information
• Section 15. Regulatory information
• Section 16. Other information, including date of preparation or last revision

The Globally Harmonized System of Classification and Labelling of Chemicals (GHS) is a system developed to standardise the classification and labelling of chemicals worldwide. GHS allows an internationally recognised method for the identification and communication of the hazards associated in transporting and supplying chemicals across the world.

In Europe, GHS is implemented via Classification, Labelling and packaging (CLP) Regulation (EC) 1272/2008. The Safety Data Sheet follows 16-point GHS format and must be in the language of the Member State.

In the USA manufacturers, distributors and importers of cosmetic ingredients and chemicals are required to comply with GHS in the workplace through Occupational Safety & Health Administration’s Hazard Communication Standard (OSHA). Requiring the completion of a standard 16-point GHS SDS.

For more information about how we can support you with Safety Data Sheets or Poison Centre Notifications, please contact us.

Following the ongoing success of our VeganSure testing service, we can now supply vegan dehydrated culture media (DCM) worldwide. So, if your testing facilities for vegan beauty and cosmetics products are in-house or sub-contracted, you can perform routine microbiological testing and assure the safety of your vegan cosmetic products, in line with your brand’s ethical stance.

All VeganSure DCM products are validated against traditional media to ensure quality of results and meet the requirements of the UK and EU Cosmetic Regulations. All animal-derived ingredients usually found in standard culture media and neutralisers are replaced with plant-based or synthetic alternatives, such as papaya-derived enzymes, soya bean, and plant peptones. The VeganSure DCM collection comprises eight products:

• VeganSure® Agar (VSA). A general-purpose agar, which supports the growth of a wide range of microorganisms. It can be used as a vegan alternative to Tryptone Soy Agar (TSA).
• Potato Dextrose Agar (PDA). Used for the preparation and maintenance of fungal test strains used in the growth promotion test. The extract from potato and dextrose provides a nutritionally rich base that encourages mould sporulation and pigment production.
• V7 Neutralising Broth (VN7). This VeganSure neutraliser covers the broadest range of preservatives and is recommended for use in challenge testing of water-miscible cosmetics.
• Vegan Maximum Recovery Diluent (VMRD). Used as an isotonic diluent for maximum recovery of microorganisms.
• Sabouraud Dextrose Agar (SDA). Used for the preparation and maintenance of fungal test strains used in the growth promotion test.
• VeganSure® Broth (VSB). A vegan alternative to Tryptic Soy Broth (Soybean-Casein Digest Broth), this is used for the cultivation of a wide variety of microorganisms and recommended for testing bacterial contaminants in cosmetics.
• V Nutrient Agar (VNA). A general-purpose medium for the cultivation of a wide variety of organisms that are not demanding in their nutritional requirements, for example, organisms that can be isolated from air, water, dust etc.
• V Nutrient Broth (VNB). A vegan alternative to traditional nutrient broth and used for the cultivation of a wide variety of microorganisms.

Suitable for all cosmetic microbiological testing, VeganSure® Agar (VSA), V7 Neutralising Broth, Vegan Maximum Recovery Diluent (VMRD), and Potato Dextrose Agar (PDA) are registered with The Vegan Society’s Trademark, meaning that companies who use them can claim the VeganSure stamp of approval, without having to be physically audited by The Vegan Society.

Registration of Sabouraud Dextrose Agar (SDA), VeganSure® Broth (VSB), V Nutrient Agar, and V Nutrient Broth with The Vegan Society’s Trademark is underway.

Additionally, the media is sold in handy single 1L shot sachets and all packaging is either 100% recyclable or biodegradable.

Please click here for more information, about our VeganSure DCM, including technical specifications.

To order VeganSure® DCM, or for any further information, please contact us.

For cleanroom and sterile environments especially, it is imperative that whole room decontamination systems, such as disinfection devices that use ultraviolet radiation, have proven efficacy. In March 2022, new method BS 8628:2022 was published; this covers the requirements and methodology for testing the efficacy of UV devices. We are pleased to offer testing to this industry standard at our in-house laboratories to assure companies that the UV disinfection system employed at their facilities is both suitable for use and effective against the organisms that pose the greatest risks.

Largely based on the existing airborne disinfection standard EN 17272:2020, with some minor variations for UV devices, this method standardises a distance for the emitter from a test surface, allowing for an assessment of power vs contact time for the UV unit. It covers the requirements and methodology for testing the efficacy of UV devices, determining bactericidal, mycobactericidal, sporicidal, yeasticidal, fungicidal, virucidal and phagocidal activities.

Previously, remote UV systems had no formal guidance on their effectiveness. The assumption of efficacy had been based on available research papers and in-house test methods of multiple testing labs or research facilities, which means that each different machine may have been tested in completely different ways – if it has undergone testing at all.

Any facility employing the use of disinfection using ultraviolet radiation should ensure that they are aware of the changes now in effect and whether their system is fit for use under the new guidance. To book a test or for further information or advice, please contact us.