ASKED & ANSWERED

F A Q

cosmetics

COSMETIC PRODUCT GENERAL

Cosmetic product is “any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odors” (article 1 of European regulation 1223/2009).

  • artificial nails or false eyelashes,
  • hair extensions,
  • wigs,
  • tooth floss
  • wipes (become cosmetics when impregnated by a substance or mixture)
  • tounge brushes
  • tablets or chewing gums
  • nasals sprays

Borderline cases are those cases where it is not clear from the outset whether a given product is a cosmetic product, medical device, toy, drug etc. or not.

When determining whether certain product is cosmetic product or not, National authorities, must proceed on a case-by-case basis, taking in account of all the characteristics of the product.

Often borderline cosmetic products are tooth whitening or bleaching products, washable, temporary “tattoos, wet razors releasing substances/mixtures, products which, according to their presentation, are destined to be used as make-up on children etc.

  • Products which are not a substance or mixture
  • Products which can be ingested, inhaled, injected or implanted into human body
  • Products whose primary function is not cosmetic

Product classification is always done on a case-by-case basis.

My cosmetic product and EU Regulation 1223/2009

Yes. In article 13 of Regulation 1223/2009 it is clearly stated that all cosmetic products that will be placed on the market in the European Union need to be registered into CPNP prior to being placed on this market.

In EU applicable legislation for cosmetic products is Regulation 1223/2009 on cosmetic products with its Annexes. Additionally claims, claims support and advertising is arranging regulation 655/2013 which is laying down common criteria for the justification of claims used in relation to cosmetic products.

Yes, regulation 1223/2009 considers perfumes and soaps as cosmetic product, since by definition Cosmetic product is “any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odors”.

Yes, it applies to all products, however they are placed on the market under condition that they fall under definition of a cosmetic product.

Product information file (PIF)

PIF is abbreviation for Product information file. PIF includes all information on cosmetic product and is to be kept for a period of ten years following the date on which the last batch of the cosmetic product was placed on the market.

  • a description of the cosmetic product
  • the cosmetic product safety report

PART A:

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

PART B:

  1. Assessment conclusion
  2. Labelled warnings and instructions of use
  3. Reasoning
  4. Assessor’s credentials and approval of part B
  • a description of the method of manufacturing and a state­ment on compliance with good manufacturing practice
  • Proof of the effects claimed
  • Data on animal testing

The responsible person shall make the product information file (PIF) readily accessible in electronic or other format at his address indicated on the label to the competent authority of the Member State in which the file is kept.

Responsible person shall, further to a reasoned request from a competent national authority, provide documentation from Product information file and additional documentation necessary to demonstrate the conformity of specific aspects of the product, in a language which can be easily understood by that authority. Burstein & Waymore team accepts documentation in English language. Also PIF is prepared in English language.

Product information file can be revised by competent authority of the Member State where the file is located.

Reponsible person for cosmetic products

  1. Responsible person (RP) is the manufacturer within the EU.
  2. The manufacturer may designate, by written mandate, a person established within the Community as the responsible person who shall accept in writing.
  3. If a product is manufactured in EU, but manufacturer is based outside EU, manufacturer needs to designate by written mandate a Responsible person who shall accept in writing.
  4. For an imported cosmetic product, each importer shall be the Responsible person for the specific cosmetic product he places on the market. The importer may, by written mandate, designate a person established within the Community the Responsible person who shall accept in writing.
  5. The distributor shall be the responsible person where he places a cosmetic product on the market under his name or trademark or modifies a product already placed on the market in such a way that compliance with the applicable requirements may be affected – for example, repackaging or relabelling of a product.

Being a Responsible person in EU is not just a function, but more a serious full-time job.

For each cosmetic product placed on the market, the responsible person shall ensure compliance with the relevant obligations set out in Regulation 1223/2009.

 

Responsible person is not only morally but also legally and financially responsible for ensuring full compliance on:

  • Safety of cosmetic product, where product made available on the market shall be safe for human health when used under normal or reasonably foreseeable conditions of use.
  • Responsible person needs to assure that the manufacture of cosmetic products shall comply with good manufacturing practice.
  • Before product is placed on EU market, responsible person needs to ensure that the cosmetic product has undergone a safety assessment based on the relevant information and that a cosmetic product safety report is set up in accordance with Annex I of above-mentioned Regulation 1223/2009.
  • Product information file shall be kept by the responsible person on the address indicated on the label. The product information file shall be kept for a period of ten years following the date on which the last batch of the cosmetic product was placed on the market.
  • Responsible person needs to take care that sampling and analysis of products have been performed in a reliable and reproducible manner.
  • Prior to placing the cosmetic product on the market, the responsible person shall submit requested information to the Commission electronically thru Cosmetic product notification portal (CPNP).
  • Responsible person obligation is to ensure that cosmetic product shall not contain
    • prohibited substances listed in Annex II
    • restricted substances which are not used in accordance with the restrictions laid down in Annex III;
    • colorants other than those listed in Annex IV
    • preservatives other than those listed in Annex V
    • UV-filters other than those listed in Annex VI
  • If product includes substances classified as CMR substances, responsible person shall ensure that those substances fall in category 2, which may be used in cosmetic products where the substance has been evaluated by the SCCS and found safe for use in cosmetic products.
  • Responsible person shall, in cases when cosmetic product contains nanomaterials, notify products to the Commission by electronic means six months prior to being placed on the market.
  • Responsible person shall ensure that level of traces of prohibited substances will be minimalized, nevertheless the non-intended presence of a small quantity of a prohibited substance, stemming from impurities of natural or synthetic ingredients, the manufacturing process, storage, migration from packaging, which is technically unavoidable in good manufacturing practice, shall be permitted provided that such presence shall not influence safety of a product.
  • Animal testing is banned in EU, therefore Responsible person shall ensure that no products, where final formulation and cosmetic ingredients were tested on animals will be placed on the EU market.
  • Responsible person needs to take care, that cosmetic products shall be made available on the market only where the container and packaging of cosmetic products bear the requirements of Regulation 1223/2009.
  • Product claims on the label need to be revised by a Responsible person and all claims should not use text, names, trademarks, pictures and figurative or other signs to imply that these products have characteristics or functions which they do not have.
  • Responsible person needs to grant public certain access to information meant for the general public
  • In the event of serious undesirable effects, the responsible person and distributors shall without delay notify the competent authority of the Member State where the serious undesirable effect occurred and cooperate with authority.
  • In the event of serious doubt regarding the safety of any substance contained in cosmetic products, the competent authority of a Member State in which a product containing such a substance is made available on the market may by reasoned request require the responsible person to submit a list of all cosmetic products for which he is responsible and which contain this substance. The list shall indicate the concentration of this substance in the cosmetic products.

Labelling of a cosmetic product

  1. The name or registered name and the address of the responsible person.
  2. The country of origin shall be specified for imported cosmetic products.
  3. The nominal content at the time of packaging.
  4. The date until which the cosmetic product, stored under appropriate conditions, will continue to fulfil its initial function. Indication of the date of minimum durability shall not be mandatory for cosmetic products with a minimum durability of more than 30 months.
  5. Particular precautions to be observed in use, and at least those listed in Annexes III to VI and any special precautionary information on cosmetic products for professional use.
  6. The batch number of manufacture or the reference for identifying the cosmetic product.
  7. The function of the cosmetic product, unless it is clear from its presentation.
  8. List of ingredients. This information may be indicated on the packaging alone. The list shall be preceded by the term ‘ingredients’.

Different types of evidential support can be used to substantiate claims. It is usual to substantiate claims by using either experimental studies or consumer perception tests and/or published information or, indeed, a combination of these.

Where it is impossible for practical reasons to label the information mentioned, for precautions and ingredients the following applies:

  • the information on precautions and ingredients shall be mentioned on an enclosed or attached leaflet, label, tape, tag or card;
  • unless impracticable, this information shall be referred to by abbreviated information or the open book symbol.

In the case of “free from claims” it is hard to determine in one sentence what is allowed and what prohibited. This decision is done on a case by case study, since it is of high importance to avoid misleading claims, unfair competition, creating confusion with a product of a competitor etc.

Expiration date/date of durability must be indicated onto packaging in case where shelf life of the product is lower than 30 months. Indication of the date of minimum durability shall not be mandatory for cosmetic products with a minimum durability of more than 30 months. For products with minimum durability longer than 30 months, there shall be an indication of the period after opening (PAO), expressed in months, in which the product can be used safely.

If you follow criteria set in Regulation 655/2013 below, you can prepare marketing material for your product easier. Claims on cosmetic products should conform to the following common criteria:

  1. Legal compliance
  2. Truthfulness
  3. Evidential support
  4. Honesty
  5. Fairness
  6. Informed decision-making

These common criteria are of equal importance.

Safety assessment, documentation and notification into CPNP

Yes. Procedure of notification of a product which contains nano ingredients should be done 6 months prior to placing this product on the EU market. Exception is made for products containing nanomaterials if they were already placed on the EU market by the same RP before the January 11th, 2013 (when Regulation 1223/2009 came into force).

Our usual lead time for performing safety assessment, Product information file (PIF) and CPNP notification is 5 working days after receiving all required information.

Yes, European online stores are also part of European market, therefore you must comply with all obligations of Cosmetics Regulation (EC) 1223/2009.

In order to perform services on highest level possible, we require formulation with exact percentages. Data confidentiality is covered by non-disclosure agreement (NDA), also known as confidentiality agreement (CA), which is a legally binding us to keep confidential material, knowledge, or information that client reveals in process of evaluation, strictly confidential.

IFRA is abbreviation for the International Fragrance Association, which is global representative body of the fragrance industry. IFRA was founded in 1973 in Geneva.

It is representing collective interests of the industry and promote the safe use of fragrances. IFRA publishes a list of usage standards for fragrance materials, limiting or prohibiting the use of ingredients, based on the findings of the Research Institute of Fragrance Materials, which gathers data regarding the safety of fragrance materials. This standard may limit or ban the use of a certain fragrance. Latest IFRA certificate is part of documents requested when preparing Safety assessment in case your product includes fragrance.

Cosmetovigilance is defined as the constant collection, evaluation and monitoring of spontaneous reports of undesirable events and serious undesirable effects observed during or after normal or reasonably foreseeable use of a cosmetic product and taking appropriate measures.

Undesirable effect means an adverse reaction for human health attributable to the normal or reasonably foreseeable use of a cosmetic product. Undesirable Effects include but are not limited to irritant or allergic reactions that can affect the skin, eyes or mouth. Undesirable effects caused by product misuse and abuse are not included in this definition.

In very rare cases an undesirable effect could be serious. Article 2.1 (p) of Regulation 1223/2009 describes SUE as »Serious undesirable effect’ means an undesirable effect which results in temporary or permanent functional incapacity, disability, hospitalisation, congenital anomalies or an immediate vital risk or death.«

Within the EU, animal testing is prohibited since 11 March 2009. In March 2013, the EU completed the ban on the sale of animal-tested cosmetics. The ban applies to both cosmetics products and ingredients.

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