Cosmetics
Safe and responsible products
At SigillumKS, we ensure that cosmetic products comply with all standards and regulations, promoting a safe and responsible cosmetics industry.
Services
Our experts in cosmetics regulation have a combined 20 years of experience and have extensive experience evaluating all types of cosmetic products: perfumes, makeup, soaps, skincare products, sunscreens, cosmetic for children and baby, etc
Regulation of cosmetic products
Responsible Person at European Union and United Kingdom
We ensure regulatory compliance and assume the role of Responsible Person in the European Union and the United Kingdom
Laboratory testing management
We manage all necessary tests for commercialization, optimizing time and costs.
Sustainability
We create sustainability strategies to ensure the production of more sustainable products.
Corporate standards definition
We help define the corporate strategy, aligned with legislation and market demands
Training
We provide specialized training on aspects related to cosmetics regulation.
European Cosmetics Regulation
To successfully sell cosmetic products in Europe, it is essential to have a detailed understanding of European regulation, with particular attention to Regulation (EC) No 1223/2009 on cosmetic products, as well as the different guidelines and regulations of each member state. Ensuring the safety of the product and compliance with all legal requirements (registration, documentation, labelling, etc.) is crucial to avoid product recalls and the resulting reputational and economic implications.
With our service, we ensure that products comply with all legal requirements through the following steps:
- Review of formula compliance
- Advice on legally required tests to ensure product safety and efficacy
- Safety evaluation and drafting of CPSR
- Labeling and claims verification
- Notification to CPNP
- Drafting of Cosmetic Product Information File (PIF)
United Kingdom Cosmetics Regulation
After Brexit, to sell cosmetic products in the UK, it is necessary to comply with the requirements of the national legislation known as "UK Cosmetics Regulation", established by "The Product Safety and Metrology etc. (Amendment, etc.) (Eu Exit) Regulations 2019, Schedule 34". This legislation includes, among other requirements, the need to have a Person Responsible (PR) based in the United Kingdom.
With our service, we ensure that products comply with all legal requirements through the following steps:
- Review of formula compliance
- Advice on legally required tests to ensure product safety and efficacy
- Safety evaluation and drafting of CPSR
- Labeling and claims verification
- Notification to SCPN
- Preparation of the Product Information File (PIF)
United States of America Cosmetics Regulation
This law's primary objective is to enhance consumer safety through increased control of the supply chain, affecting manufacturers, importers, packagers, and distributors of cosmetic products.
MoCRA-US FDA Services
Facility registration
According to the MoCRA law, non-American manufacturers seeking to enter the U.S. market must register all their facilities on the FDA's web portal and designate a representative in the country, known as the U.S. Agent.
From our subsidiary in the United States, we can handle the registration of facilities and serve as your Legal Agent.
Product Listing
MoCRA requires the Responsible Person for a Cosmetic Product to ensure that each cosmetic product is registered on the FDA portal, providing evidence of the cosmetic product's safety in accordance with the new legislation. This product registration must be renewed every two years.
SigillumKS has expert advisors who can assist you in the registration process and ensure compliance of cosmetic products with the new safety and labelling regulations.
Product Evaluation and Labeling Review according to US-FDA
SigillumKS can assist you in verifying the safety of the formula and labeling, in accordance with the criteria set by the FDA, Proposition 65 in California, the California Safe Cosmetics Program, or the legislation of any other state.
Legal Agent in the United States
As a Legal Representative, SigillumKS can perform the following functions:
- Manage communication between the US-FDA and the client, providing assistance in the case of FDA inspections, inquiries, or product recalls.
- Provide support to the Responsible Person in managing their obligations under MoCRA, including:
- Maintenance of records adequately documenting the safety of cosmetic products introduced in the United States.
- Management of adverse effects:
- Registration of adverse effects and serious adverse effects, and keeping records updated.
- Reporting serious adverse events to the FDA within 15 business days of their reception.
International regulation of cosmetic products
Our Regulatory Watch Observatory is monitoring legislation in more than 60 countries on all five continents, keeping us up-to-date on any regulatory changes.
This allows us to provide advice on the necessary requirements for successfully commercializing cosmetic products in different international markets, such as Europe, USA, Canada, Mercosur, ASEAN, Australia, China, Middle East, GCC, South Korea, Japan, etc.
With our extensive coverage and experience in regulatory surveillance, we can guarantee a high-quality service that meets the needs of our clients worldwide.
Responsible Person at European Union and United Kingdom
In the European Union and the United Kingdom, selling cosmetic products requires the existence of a RESPONSIBLE PERSON (RP) established in the EU or UK and responsible for ensuring that the cosmetic products marketed comply with the legislation.
The Responsible Person can be the manufacturer, the distributor, the importer, or another entity designated as RP through a Written Mandate.
At Sigillum KS, we offer a complete service as a Responsible Person, from start to finish, ensuring compliance and product safety in both markets through:
- Providing guidance on requirements related to cosmetic products regulation in EU and UK
- Managing all required safety studies to comply with legislation in both markets
- Conducting safety evaluation, technical documentation (PIF) and all necessary registrations
- Acting as the point of contact for the brand with authorities
- Conducting cosmetovigilance and managing any potential issues with customers if necessary.
Laboratory test managing
Bringing cosmetic products to market requires different laboratory tests to ensure their safety and efficacy.
By knowing which tests are required for each market is possible avoid problems with commercialization or with authorities, as well as optimize the number of tests needed, saving costs and time.
SigillumKS works with different laboratories to conduct all the necessary tests, managing the entire process from the initial order to the analysis of the results.
Sustainability
Nowadays a company must be committed to minimizing its environmental and social impact. Adopting more sustainable practices such as the use of natural ingredients, reducing packaging, using efficient and sustainable production practices or improving transparency in the supply chain are some of the ways to achieve a more sustainable production.
With our services, we ensure the requirements for the manufacturing of more sustainable products by:
- Creating indicators for the evaluation of the sustainability of cosmetic products
- Advising on more efficient practices • Advising on natural and organic ingredients
- Advising on more sustainable packaging
- Advising on sustainable labelling.
Our extensive experience in sustainability and our science-based approach allows us to advise companies on improving their sustainability practices according to their corporate philosophy, focusing on what has the greatest impact on their product and avoiding the practice of "greenwashing".
Corporate standards definition
The growing consumer awareness and market demand are driving the trend towards the creation of cosmetic products that meet specific requirements, such as being classified as "clean beauty", vegan products, gluten-free products, or free of genetically modified ingredients (GMOs).
At our company, we have extensive experience and knowledge in creating corporate standards and guidelines for permitted or prohibited ingredients to meet these requirements, providing our clients with safe and innovative solutions that fit market demands.
Training
Our experience and knowledge allow us to provide specialized training in any of the aspects related to cosmetics product legislation:
- International regulatory framework for cosmetic products
- Regulatory training for technical and production units
- Responsible person and PIF requirements
- Risk management
- Sustainability in the cosmetic industry