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Your obligations and responsibilities depend on your role in the production, distribution and/or the sales of cosmetics products and where you are located. The safety and regulatory compliance of each cosmetic product on the EU market shall be ensured by the “Responsible Person”.

EU manufacturer

For a cosmetic product manufactured within the EU and not subsequently exported and imported back into the EU, the EU manufacturer is the Responsible Person.

Any manufacturer

All manufacturers located inside or outside the EU shall ensure that the manufacturing of a cosmetic product complies with good manufacturing practices (GMP).

EU importer

For an imported cosmetic product, each individual EU importer shall be the Responsible Person for the specific cosmetic product he makes available on the market. Individual batches of a single cosmetic product can be imported by multiple EU importers where each individual EU importer is considered a Responsible Person for the quantities of the cosmetic product it imports. In the case of multiple importers, we typically see one single (3rd party) Responsible Person that is appointed through a signed RP mandate.

EU distributor

In the context of their activities, shall act with due care in relation to the applicable requirements. A distributor shall verify labelling information, language and the minimum durability date specified on the product. In addition, he shall act on suspicions of non-compliance and non-safe products ensuring products will not be placed on the market and/or eliminate the risks of products already on the market.

3rd party Responsible Person

EU manufacturers and EU importers may designate, by written mandate, a legal entity or person established within the EU as the Responsible Person who must accept this mandate in writing. Both parties approve by signature. At TRC, we work with standardised a short RP mandate template.

The obligations of the Responsible Person are many and are all geared to ensuring compliance and safety of the cosmetic product. The RP shall always cooperate with the authorities providing all data deemed necessary in a language easily understood by the authority.

The role of the Responsible Person (RP) may automatically fall to you depending on your company activities and/or the location of your company (within/outside) the EU or can be assigned to a 3rd party service provider such as The Regulatory Company.

  1. Ensuring safety for human health under normal and reasonably foreseeable conditions of use (including labelling, instructions and warnings)
  2. Compliance with good manufacturing practice
  3. Performance and continuous updating of the safety assessment
  4. Building and maintaining a product information file
  5. Sampling and analysis of a cosmetic product
  6. CPNP notification prior to placing a cosmetic product on the market
  7. Product composition in accordance with the annexes II-VI of the Cosmetics Regulation and updates thereof
  8. Product composition not to contain CMR substances
  9. Proper evaluation and notification of a cosmetic product containing nanomaterials
  10. Product safety with regards to the non-intended and technically unavoidable presence of prohibited substances under GMP
  11. Compliance with non-animal testing requirements
  12. Compliant product labelling
  13. Public access to product composition data, specifically regarding hazardous substances, and the history of (seriously) undesirable effects
  14. Product claims in line and limited to the characteristics and functions of a cosmetic product
  15. Timely communication and adequate handling in the event of a serious undesirable effect (also applies to distributors)
  16. Traceability of raw materials and substances in all cosmetic products under the RP’s responsibility

The Responsible Person (RP) must be in possession of the full product information file (PIF) for each cosmetic product on the EU market. The dossier can be regarded as a product’s “passport” for the EU market. Product dossiers must always be available to the competent authorities for inspection at the premises of the RP within 72 hours following on the request.

PIF Data and documents

A large part of the PIF is essential input for the mandatory safety assessment. The dossier contains essential information regarding the product composition, raw materials, purity, safety (toxicology), stability, claim support, etc.

As a minimum the PIF contains the following:

  1. Product label / artwork as presented to consumers in the relevant EU member states
  2. Image of the product as presented to consumers
  3. Product presentation, marketing (claims) information and product brochures
  4. Product formulation (exact qualitative and quantitative composition)
  5. Individual raw material information, typically the MSDS and CoA, and in some cases the TDS, purity and/or declarations of the absence of specific frequent contaminants when relevant; e.g. quantification of 1,4-dioxane in PEGylated compounds). For parfums an allergen statement (quantification) and IFRA declaration are required.
  6. Finished product specification (SPEC) and Certificate of Analysis (CoA)
  7. No animal testing declaration (raw materials and/or the finished product
  8. Manufacturing method / production process flow
  9. If applicable: stability test report and minimum durability/PAO conclusions (to justify minimum durability date)
  10. If applicable: microbiological quality and stability including preservation efficacy test (PET/challenge test) data according to current ISO standard for cosmetic products
  11. If applicable (e.g. in the case of skin-irritation potential): skin compatibility and non-irritation test data (clinical study on human volunteers or a validated alternative in-vitro test method)
  12. If applicable (e.g. in the case of (implicit) claims): scientific claim substantiation for each specific activity/effect claim
  13. Proof of traceability

When all required information and testing data is available and the product is compliant and safe, all services including CPNP notification can be executed within 2-3 weeks if there are no limiting 3rd party dependencies. We regularly see that producers are not able and/or not willing to share detailed information. In most cases, we can work under a NDA agreement. After CPNP notification a cosmetic product can be placed on the EU market.

Lead-times, the PIF and dependencies

The PIF is central to the regulatory work field. A complete and up-to-date PIF will enable a short and efficient safety and compliance process including CPNP notification from start to finish.

Delays are mostly caused by information/documents that need to be chased internally or at suppliers and/or when testing needs to be executed such as: accelerated stability tests (+/- 3-6 months); microbiological quality and stability including preservation efficacy (PET/challenge) tests (4-8 weeks); if needed patch/exposure tests (3-5 weeks); if needed claim support studies (duration dependent on claim and study approach); and/or when labelling including claims need to be adjusted.

It is important to have a basic understanding of the EU Cosmetics Regulation when you expect to place your products on the EU market at some stage. This will enable you to estimate lead-times, lower hurdles and reduce efforts and costs considerably once the commercial opportunities are there.

Taking the basics into account early on

There are regulatory differences and varying approaches to in-market control between regions and countries. A product may be fully compliant in the US, while at the same time additional testing/information may be needed for the EU, and labels and claims may need to be adjusted. And the EU requires that an EU based legal entity or person assumes responsibility for the products as the “Responsible Person”.

The EU Cosmetics Regulation regulates many key aspects, for example: production has to be in line with GMP principles; the raw materials that you source have to be well documented (e.g. MSDS, TDS, CoA); your formulations have to be compliant with the substance bans, restrictions and quality requirements; the claims that can be made for cosmetic products are regulated and enforced and may require substantiation; and it is important to understand the duties and responsibilities you and/or your importers into the EU have.

Benefit when placing your products on the EU market

Knowing the basics early on, even before concrete EU market opportunities come up, will help you to make the right choices now in selecting your suppliers and ingredients, in developing your formulations, in deciding on your product positioning and claims, and in rolling out your EU sales and distribution channels.

This way you will avoid the need to switch suppliers, to adjust your formulations and/or to adjust the product claims potentially rendering it a very different (value) positioning. In addition, it will prepare you for questions about EU regulatory compliance and EU notification that potential buyers will surely have and will use as vetting criteria before deciding to partner with you.

Your business will benefit most if you yourself focus on core value attributing activities such as innovation, formulation, design, marketing and sales. Regulatory work should be managed efficiently and effectively support you and your commercial objectives without you having to manage various service providers (e.g. laboratories) and regulatory experts (e.g. SA, RP).

Alignment of interests

Alignment of capabilities and interests is key. The primary business of a testing laboratory is performing tests. A safety assessor will assess your products in a one-time effort only. The Responsible Person should continuously ensure compliance with the EU Cosmetics Regulation and safety of the cosmetic product.

Having one single service provider to act on your behalf, equipped with the (legally) required capabilities as a safety assessor (SA), requiring only the strictly necessary testing to be performed, and assuming legal liability as the Responsible Person (RP) for your products is the best solution. It is in the interest of the RP that the PIF and the safety assessment are complete, up-to-date and of the highest quality at all times. This will give you the best guarantees and peace of mind.

How we work at TRC

To foster full alignment of interests with clients, TRC prefers to work in an all-in full-service set-up without unexpected costs along the way. In this set-up, we do not charge additionally for advice; not for updated safety assessments because of changes in raw material compositions and product reformulations; not for updates of labels, claims and CPNP notifications; and not for representation towards authorities and guiding authority inspections. Performing all activities in-house with our PRIMS Compliance Software ensures full control and high efficiency.

At TRC we only require additional testing to be done when the raw materials and/or product formulation give reason to do so, and when testing has not been performed yet by you or your suppliers. We have no commercial stakes or interests in the laboratories that we can recommend to you for analytical or in-vivo testing.

It is important to properly weigh total costs and benefits. Total costs for regulatory work may spiral out of control when adding all direct and indirect costs and efforts from your side that go into it. And the impact of non-compliance and (temporary) loss of market access may permanently damage your commercial activities, in particular when you work with long-term distribution and sales relations in the EU.

Fixed fee per product and product variant per year

At TRC we charge a fixed fee per product per quarter with all of our services included. This way you are ensured that no additional costs are charged for help with getting your PIF together, the safety assessment performed and updated over time, your labels and claims reviewed any time you redesign your products, your products (re)notified in CPNP whenever details change and/or when TRC represents you in case of authority inspection.

Only when testing is needed, we will recommend on testing requirements and a testing laboratory. A testing laboratory is directly contracted and paid by you without any interest or stake for TRC, except for ensuring high-quality test results to support our services.

For product portfolio’s that include formulation variations of a single base formula we work with strongly reduced fees. Some examples are soaps, shampoos, lip glosses that are offered in several fragrance/flavour/colour variants; and lipsticks, eye shadows, nail polishes that are offered in many shades.

At TRC we always start with your portfolio, formulations, data and documents and most importantly with your commercial priorities and timelines. As a first step we assess the possibilities for EU CPNP notification and estimate lead-times and needed resources by yourself and TRC.

Start to collect your data and documents

Even before beginning to discuss any formal contract details, we start the process with a quick scan of your portfolio and product positioning, for example on your website or in a product brochure.

Contact us

A scan of your raw material and product formulations, and the supporting data and documents gives our experienced senior experts immediate insights.

Based on your commercial priorities and timelines, we will discuss when to start, what part of your portfolio to focus on, and which activities to start with that are on the critical time path towards meeting your deadlines. We will also be able to identify and highlight potential interdependencies and risks.

Get started: contact us at info@theregcom.com / +31 70 2213180

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