COSMETICS REGISTRATION
IN THE EUROPEAN UNION

SAFETY ASSESSMENT SERVICES

We register cosmetics in the European Union in accordance with EC Regulation 1223/2009. We provide a comprehensive service - arrange a comprehensive Safety Assessment with preparation of CPSR and PIF, arrange basic and extended laboratory testing to verify marketing claims and product features, provide label drafts and support the packaging design process under EU requirements. Contact us for an offer.

RP SERVICES AND CPNP REGISTRATION

We intermediate the signing of an RP service agreement with our Responsible Person partner and the transfer of responsibility for cosmetic products including registration in the CPNP. We ensure attractive contracted pricing terms for our clients. We do not charge an additional fee for this service. You individually pay the Responsible Person annually for its service. We support you at every step.

REGISTRATION IN 3 MONTHS

The overall process time from the start of the Safety Assessment to registration with the CPNP is approximately three months. The final time depends primarily on the speed with which the product and substance documentation is completed by the manufacturer. The documentation is carried out in English.

EUROPEAN UNION REQUIREMENTS

Cosmetic products placed on the market in the European Union are regulated, i.a. by Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products. This means that every cosmetic product has to undergo a detailed Safety Assessment with lab tests, a CPSR and a PIF must be prepared, a Responsible Person must be designated in the EU and an registration must be made in the CPNP portal before cosmetic can be placed on the EU market.

KNOWLEDGE BASE

SAFETY ASSESSMENT

Safety Assessment is a procedure for assessing the safety of cosmetics, carried out by a person with the appropriate competence and knowledge called a Safety Assessor. The Safety Assessor verifies in detail the composition of the cosmetic for safety and compliance with EU regulations, verifies the product, substance and packaging documentation, determines the tests necessary to be performed and verifies the results of these tests. He determines the necessary labelling of the product with warnings, verifies the marketing claims based on the tests performed, prepares the CPSR and PIF. 

FLOW OF THE PROCEDURE

PHASE I
  • In the initial stage of the Safety Assessment, a preliminary assessment of the cosmetic formulation is carried out. If a substance is found to be non-compliant, we and the Safety Assessor support you in adjusting the formulation to EU regulations before the final Safety Assessment begins and laboratory tests are ordered. This approach allows you to check if your product formulation is suitable for the EU market before you bear the first costs.

FLOW OF THE PROCEDURE

PHASE II
  • You provide us with the documents we ask for (MSDS, COA, CGMP, declarations, expected product function) we take care of the rest.
  • The Safety Assessor verifies the documentation, performs the calculations and approves the final product formula.
  • We keep you regularly informed throughout the process. We are in regular contact with the Safety Assessor and the RP.
  • We support you in the process of drafting marketing declarations and arrange laboratory tests.
  • We provide Label Drafts and verify the design of your packaging.
  • Finally, you receive the test results, the CPSR and the PIF.
  • From the RP you receive confirmation of CPNP registration.

RP

RESPONSIBLE PERSON

According to EC Regulation 1223/2009, every cosmetic product placed on the EU market must have a designated Responsible Person (RP) based in the EU. According to Article 4 of EC Regulation 1223/2009, the responsible person is the legal or natural person ensuring that any cosmetic product on the EU market complies with all relevant legislation. This role can be carried out by the manufacturer (if based in the EU), the importer, the distributor or a designated third party based in the EU. Compliance with these obligations is essential to maintain product safety and regulatory compliance in the European Union.
You can transfer the responsibility for cosmetics produced outside the EU to a third party - the RP. The RP then approves the Safety Assessment (PIF) and registers the product with the CPNP. The RP signs an RP contract with you. Your customers (EU importers) join this contract by signing a written mandate with the RP. The RP also informs you if any information needs to be updated or changes need to be made to the product if current regulations require it.
RP keeps the PIF of your products for 10 years and is involved in any inspections by the Authorities instead of you.

CPSR

COSMETIC PRODUCT SAFETY REPORT

PART A – COSMETIC PRODUCT SAFETY INFORMATION

  1. Quantitative and qualitative composition of the cosmetic product
  2. Physical / chemical properties and stability of the cosmetic product
  3. Microbiological quality
  4. Impurities, traces, information on the packaging material
  5. Normal and reasonably foreseeable use
  6. Exposure to a cosmetic product
  7. Exposure to the substance
  8. Toxicological profile of the substances
  9. Undesirable effects and serious side effects
  10. Information on the cosmetic product

PART B – COSMETIC PRODUCT SAFETY ASSESSMENT

  1. Assessment conclusion
  2. Label warnings and instructions for use
  3. Reasoning
  4. Assessor’s credentials and approval of Part B 

PIF

PRODUCT INFORMATION FILE

Complete product documentation including:

  • CPSR
  • Manufacturer's declarations (packaging, product, CGMP, no animal testing)
  • Cosmetic formulation ( ingredients list)
  • Product specification and Label Draft
  • Laboratory test results

The PIF must be kept for 10 years after the last batch of the product has been placed on the EU market. These documents are confidential and controlled by the Authorities.

LABORATORY TESTS

BASIC TESTS
  • Microbiological Test
  • Dermatological Test / Patch Test
  • Challenge Test
  • Stability Test
  • Compatibility Test
  • Heavy Metals Test
  • other tests if necessery

LABORATORY TESTS

OPTIONAL EFFICACY TESTS – CONFIRMATION OF MARKETING CLAIMS AND PRODUCT’S PROPERTIES

  • Use Test
  • Instrumental tests
  • SPF Test
  • UVA Test

LABEL DRAFT

According to EC Regulation 1223/2009, mandatory information should be labelled on packaging. Labels, lettering and symbols should be indelible, easily legible and visible. Information on the packaging shall include, a.o. ingredients list, product description, warnings, directions for use, date of minimum durability, PAO symbol, batch number, country of origin and other symbols and indications depending on the individual characteristics of the cosmetic product.

CPNP

COSMETICS PRODUCT NOTIFICATION PORTAL 

According to EC Regulation 1223/2009, all cosmetic products placed on the EU market must be registered in an online registration system called CPNP. Only the Responsible Person of a cosmetic product can notify cosmetic products to the CPNP. The RP provides the product composition, labels, images and other necessary data. Each product receives a unique registration number in the CPNP. This system is used by the authorities to control and collect information on cosmetics in the EU. Having an CPNP registration does not mean that the product meets all the requirements of the EU regulation.