Cosmetic products
Description of cosmetic products’ notification procedure
The information application about a cosmetic product
On May 1, 2004 the Regulations No. 354 of the Cabinet of Ministers of the Republic of Latvia “Essential Requirements for Cosmetic Products, Labelling thereof and Procedures for Supervision of Compliance with these Requirements” took effect (further in text-Regulations). These Regulations contain legal norms arising from the directives 76/768/EEC and 95/17/EC. Points 61 and 62 of Regulations declare that:
“61. Prior to the placing of a cosmetic product on the Latvian market, the producer or the prime importer, if located in Latvia, shall notify the State Sanitary Inspection [1] of the address of the place of production or first importation of the cosmetic product.
62. Prior to the placing of a cosmetic product on the Latvian market, the responsible person authorised by the producer and prime importer, if located in Latvia, as well as by the distributor in Latvia of a cosmetic product manufactured in another Member State of the European Union or first imported into another Member State of the European Union, shall submit to the State Sanitary Inspection [1] the following information for the cosmetic products database:
62.1. regarding the undertaking and the responsible person – the producer, prime importer, distributor in Latvia of the cosmetic product and the responsible persons (Annex 12); and
62.2. regarding the cosmetic products placed on the Latvian market (including the qualitative and quantitative composition of the cosmetic products (Annex 13)).”
The Health inspectorate of Latvia (further- the Inspectorate) has developed a notification procedure concerning:
- Enterprise and responsible person
- Cosmetic products and their compositions;
- Cosmetic product Latvian producer’s place (address) or first importer’s place (located in Latvia).
1. The information submission for the Cosmetic Products Database regarding an enterprise and responsible person
1.1. Enterprise actions
1.1.1. Information about an enterprise “Information for the Cosmetic Products Database regarding an Undertaking and Responsible Person” is submitted according to Annex 12 of Regulations and available for electronic use in Excel format on the Inspectorate’s homepage www.vi.gov.lv under section Pakalpojumi.
1.1.2. The form should be drawn up in two copies.
1.1.3. Filling in the first part of Annex 12, called “Information regarding a legal person” of the form you must mark by putting “X” symbol opposite to the status of the enterprise – manufacturer of the cosmetic product, first importer in the EU, distributor in Latvia or multiple status. In cases when the enterprise is both the manufacturer and the first importer or near that, the entries have to be made in the appropriate items and the main status has to be underlined or formatted in bold.
1.1.4. If the enterprise is the manufacturer or the first importer of the cosmetic product, then the information required in the point 61 of Regulations has to be drawn up in two copies.
1.1.5. When attending the Inspectorate for the first time, facts about the enterprise must be provided. The manager, responsible person or additional contact person (showing an identity card or a person verification document) submits appropriately filled form in 2 copies signed by the manager and approved with the enterprise seal. For the verification of the form, the merchant registration certificate or its copy must be present. Such a copy shall have the same legal effects as the merchant certificate from which it is derived.
1.2. Inspectorate’s actions
1.2.1. The Inspectorate in accordance with submitted information (in documentary form) inputs data about the enterprise into the database. For each legal person – manufacturer, importer or a distributor of cosmetic products in Latvia, the cosmetic product database generates the client’s registration number, which is specified in the enterprise information forms. The document must be drawn up in two copies. One copy is intended for the Inspectorate’s needs, the other is returned to the submitter of the information as a confirmation of receiving documentation.
2. Information submission for the database regarding cosmetic products offered on the market in the Republic of Latvia
2.1. Enterprise actions
2.1.1. Prior to the placing of a cosmetic product on the Latvian market, information about the cosmetic product and its compositions must be submitted to the Health inspectorate by the manufacturer, first importer or distributor.
2.1.2. Information about cosmetic products and its compositions doesn’t have to be submitted repeatedly, if according to the points 46 and 51 of Regulations No. 226 “Cosmetic Product Safety Requirements and the Procedure for Supervision” of Cabinet of Ministers of 5 June 2001 (Regulations No.226 are not in force any more) it already has been declared, by submission of notification forms to the Health Inspectorate (No. 1, No. 2 or No. 3) till May 1, 2004.
The above mentioned is beside the point in such cases where the name, composition, manufacturer etc. of the cosmetic product has been changed from the data given in the notification form.
2.1.3. Information about the cosmetic products “Information for the Database of Cosmetic Products regarding Cosmetic Products Offered on the Market in the Republic of Latvia (the Qualitative and Quantitative Composition thereof)” is submitted according to Annex 13 of the Regulations, which is available for electronic use on Inspectorate’s homepage www.vi.gov.lv under section Pakalpojumi.
2.1.4. The completed form should be submitted to the Inspectorate in two copies in documentary form as well as electronically (via e-mail, CD, floppy disc or other recordable disc). E-mail address is: dati@vi.gov.lv
After the copying of necessary information, the information source is returned to the submitter.
The document must be drawn up in two copies. One copy is intended for the Inspectorate’s needs, the other is returned to the submitter of the information as a proof that the information required by the normative acts has been submitted and the enterprise can place the cosmetic product on Latvian market.
2.1.5. When completing the form No. 13 (Annex 13), the following requirements should be taken into account:
2.1.5.1. The item “Trademark” and “Title” should be specified in the original language.
2.1.5.2 The “Number of the basic type” should be indicated. It is specified in Annex 1 of Regulations. (For example, if the cosmetic product is a lipstick – number “8” should be indicated).
2.1.5.3. The item “Environment pH” must be specified only in cases, where the cosmetic product’s environment pH is below pH 3 (very sour solution) or above pH 10 (very alkaline solution). As if this cosmetic product is used in an unforeseen way, it could harm the health of the consumer.
2.1.5.4. The item “Place (address) of first importation” should be filled out only for cosmetic products which have not been produced in the European Union.
2.1.6. Information regarding the qualitative (according to INCI) and quantitative (% of mass) composition of a cosmetic product should be a certified copy of a document by the producer. Such copy must have the same legal effects as the document from which it is derived. It should be attached as a numbered annex to the form regarding the relevant cosmetic product. The number of the annex should be specified in Column 9 of the form.
The producer as an alternative may also provide information regarding the composition of a cosmetic product in accordance with the standard prescriptions developed by the European Association of Poisons Centres and Clinical Toxicologists EAPCCT and the European Cosmetic Toiletry and Perfumery Association COLIPA (Cosmetic Frame Formulations, EAPCCT/COLIPA, January 2000).
Relevant information concerning Frame Formulations can be found here: http://www.colipa.eu/publications.html?Itemid=71&task=browse&catid=2
In case the manufacturer of the cosmetic product declares in accordance with Cosmetic Frame Formulations, documentation should contain the following information:
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Manufacturer details;
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Trademark, title, type and usage of the cosmetic product;
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The Cosmetic Frame Formulation (number), which complies with the specific cosmetic product;
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Date, the person placed in charge by the manufacturer – name, surname, signature.
2.1.7. Some products are covered by Frame Formulations, but require additional information on the components that may harm the consumers the Health inspectorate in case of unforeseen usage of the product.
Without the above mentioned information there must be indicated information about the specific components name (INCI) and its quantitative composition (mass %). In accordance with EAPCCT/COLIPA recommendations about components, the following so-called additional (or risk) components are specified:
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Ethanol and/or Isopropanol,
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Antidandruff agents,
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Vitamin A and its derivatives,
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Xanthine derivatives, if the product contains more than 0.5 % xanthine derivative,
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Cationic surfactants, if its content in the product is more than 5%,
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Solvents in hairspray products,
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Solvents in permanent and semi-permanent hair colorant products,
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Solvents and/or persulfates in hair bleaches,
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Hydrogen peroxide in hair bleaches, hair dyes.
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Solvents in nail varnish products,
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Fluorine compounds in toothpastes and in mouthwash products,
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Inorganic sodium salts in bath salts/cubes.
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Essential oils (including camphor), except for perfume, if its’ level is higher than 0.5%.
2.1.8. When submitting information about the following products:
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nail cuticle removers,
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nail strengtheners,
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nail varnish removers,
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permanent wave neutralizers in powder form,
the complete data about the qualitative and quantitative composition of the cosmetic product always must be declared, i.e. Frame Formulations must not be used.
2.1.9. Information about cosmetic product specific ingredient groups and its functions can be obtained using EU Commissions Decision EU CD 96/335/EC establishing an inventory and a common nomenclature of ingredients employed in cosmetic products or one of its data bases, for example on the internet.
Database on cosmetic product ingredients can be found on EU Web page: http://ec.europa.eu/enterprise/cosmetics/html/cosm_inci_index.htm .
2.2. Inspectorate’s actions:
2.2.1. Inspectorate’s authority checks the accuracy of the information given in the form and its annexes and inputs the information to the database.
3. Updating of the information
3.1. In cases when the manufacturer changes cosmetic product’s composition keeping the previous name of the product, or an importer receives information about changing of the composition of a product from the manufacturer, the manufacturer must inform the Inspectorate about the changes, not later than 5 days after receiving new information in accordance with point 63 of the Regulations.
This is done by sending a letter containing the ingredients of the product which includes the trademark of the product, title, type, usage and a specific date from which the cosmetic product has been manufactured with the new composition. If the title (name) of the product has been changed, information about a new cosmetic product has to be resubmitted to the Health inspectorate.
4. Responsibility
4.1. In accordance with point 70 of the Regulations, the producer and the prime importer of a cosmetic product, if located in Latvia, as well as the distributor in Latvia of a cosmetic product which has been manufactured in another Member State of the European Union or which has been first imported into another Member State of the European Union shall be responsible for compliance with the requirements of these Regulations.
4.2. In accordance with Section 8 (5) and Section 8 (6) of the “Law on the Safety of Goods and Services”, before making the decision to offer the cosmetic product to the market and to deliver the information about this product and its composition to the cosmetic products database, it must be checked if the cosmetic product complies with the requirements of the Regulations.
4.3. Responsibility for not submitting information:
4.3.1. In accordance with the “Latvian Administrative Violation Code” for not submitting information or submitting incomplete information, it is indicated, that the manufacturer or the distributor can be charged with a fine.
4.3.2. For the same violation if it has been estimated repeatedly during a one year period, a fine is charged.
For the development of this procedure the EAPCCT/COLIPA and TTC (Translation and Terminology Centre) publications were used.
The Health inspectorate of Latvia provides the English language text above for information only.
[1] In accordance with Decree No 432 of the Cabinet of Ministers of the Republic of Latvia (about establishment of the Health Inspectorate), the State Sanitary Inspectorate of Latvia since October 1, 2007 has been renamed to the Health Inspectorate, as a result of reorganization. The mailing address remains the same.