Guidance for Importing Cosmetic Products

Guidance for Importing Cosmetic Products

Responsible Person
Regulation (EC) No 1223/2009 on cosmetic products, states that only a responsible
person can place a cosmetic product on the GB market. A responsible person instead can
be one of the following:

• A person in the UK designated by written mandate by a manufacturer outside of

the UK

• A distributor, where they place a cosmetic product on the market under their name
or trademark, or modify 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

• The importer (established in the UK who places a product from a country outside
the UK on the UK market)

In the absence of a UK based manufacturer or authorised representative, the duties of the

responsible person will fall to you as the importer. If this is the case, then you will need to
fulfil the legal duties below.

Duties of the Responsible Person

• Ensure that the cosmetic product has undergone a safety assessment and that a
cosmetic product safety report is produced

• Keep certain product information (see Compliance section) at the registered office
address or the address detailed on the product. This information must be easy for
Trading Standards authorities to access and can be requested if needed. The
information must be in English

• Collate the Product Information File (PIF). This should contain information about
the finished product, including evidence of safety and efficacy

• Produce a copy of the Cosmetic Safety Report (CSR). This document may also be
requested by a Trading Standards Authority

• Ensure the cosmetic product is registered on the Submit Cosmetic Products

Notifications portal (SCPN). Each new cosmetic product needs be registered using
the link Submit a cosmetic product notification - GOV.UK (www.gov.uk). The
information below needs to be provided:

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o the category of cosmetic product and its name or names, enabling its
specific identification

o the name and address of the responsible person

o the contact details of a physical person to contact in the case of necessity (if
the cosmetic product has been imported into the UK)

o the presence of substances in the form of nanomaterials and their

identification

o the frame formulation allowing for prompt and appropriate medical

treatment in the event of difficulties

o a legible photo of the final packaging

Labelling
The following information must be present on the packaging or, if the packaging is too
small by a leaflet, label, tag, tape or card enclosed with or attached to the product. This
information must be visible, indelible and easily legible:

• The name and address of the UK responsible person must be on the container
(such as a tube, bottle or jar) and the packaging (for example, the box or outer
carton). Where the product is manufactured outside the UK, the country of origin
must also be given

• Durability, where a cosmetic product has a minimum durability of 30 months or

less, it must be marked on the container and the packaging with a best-before
date or the symbol shown below

The indication must be in the form 'Best used before the end of', followed by the
date (day / month / year or month / year) or an indication of where the date
appears on the packaging. If any particular conditions must be observed to
guarantee the stated durability, these must also be described

Where a product has a shelf life of more than 30 months, it must instead be
marked with the symbol shown below together with an indication (in months, or
years and months) of the period after opening for which the product can be used
without harming the consumer

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• Precautions to be observed in use must be printed on the label (see warnings

section below). If the product is for professional use only, such as in hairdressing,
this must appear on the container and packaging

• The batch number of manufacture or the reference for identifying the goods

• The function of the product if not otherwise obvious from design and packaging

• Ingredients List: This must be clearly highlighted as ‘INGREDIENTS’ on the

packaging. The ingredients must be listed in descending order of weight. This
includes products for professional use and free samples

• The ingredient name must be that listed in the International Nomenclature of

Cosmetic Ingredients (INCI) or, if no such name is listed, one of the following:

o chemical name

o European Pharmacopoeia name

o International Non-proprietary Name (INN), as recommended by the World

Health Organisation

o European Inventory of Existing Commercial chemical Substances (EINECS),

International Union of Pure and Applied Chemistry (IUPAC), or Chemical
Abstracts Service (CAS) identification reference

o colour index number

Warnings and Instructions

The Preamble to Annex II in the Regulations defines different types of cosmetic product.
Check the Preamble, to see which category of cosmetic the product falls into, as this will
affect the substances allowed and the warnings to be applied.

Annex II, III, IV, V and VI contain a list of substances, colourants, preservatives and UV
filters prohibited or restricted in cosmetic products. Check this list to make sure the
ingredients of the product don't contain substances not allowed.

Check the tables in Annexes III to VI to find the correct wording for conditions of use,
warnings and symbols.

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All cosmetic products must include clear instructions for use, so that the product can be
used safely.

Below are some of the examples of the warnings and conditions of use by product type,
depending on the substance used:

• Hair products: not to be used by children under 3, avoid contact with eyes and
rinse eyes immediately if the product comes into contact with them

• Hair dyeing products: can cause an allergic reaction, wear suitable gloves,
follow instructions

• Certain nail products: keep out of reach of children, can cause blindness

Compliance Documentation
As an importer of cosmetic products into GB, you must ensure the products you place on
the market are safe for human health under normal or reasonably foreseeable conditions
of use. The Responsible Person section at the top of this document states in certain
circumstances you may be defined as the responsible person. Therefore, you must ensure
you can provide the relevant safety documents listed below to a Trading Standards
Authority on request.

• Product Information File (PIF). This must be kept at the address of the responsible
person, and it must contain the following information:

o A description of the product

o A copy of the Cosmetic Product Safety Report

o Details of methods of manufacture in accordance with good manufacturing

practice

o Proof of the effect claimed for the cosmetic product, where justified by the
nature or the effect of the cosmetic product

o Data on animal testing if conducted.

• Cosmetic Product Safety Report (CPSR) forms the safety assessment of the
product. The report must be compiled by a qualified safety assessor and signed off
by the responsible person. The report must:

o Consider the intended use of the cosmetic product and the anticipated
exposure to each ingredient in the final formulation

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o Apply an appropriate weight-of-evidence approach for reviewing all

sources of data

o Ensure the report is kept up to date in view of any new information

received.

• The report is split into part A and part B.

• Part A covers gathering the data required to identify and quantify from the
identified hazards, the risk that a cosmetic product may present to human health.

• Part B will provide a conclusion as to why the safety assessor believes the cosmetic
product is safe.

• Part A
o Quantitative and qualitative composition of the cosmetic product

o Physical/chemical characteristics and stability of the cosmetic product

o Microbiological quality

o Impurities, traces, information about the packaging material

o Normal and reasonable foreseeable use

o Exposure to the cosmetic product

o Exposure to the substances

o Toxicological profile of the substances

o Undesirable effects and serious undesirable effects

o Information on the cosmetic product

• Part B

o Assessment Conclusion

o Labelled warnings and instructions for use

o Reasoning

o Assessor’s credentials and approval of part B

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When sourcing your products, you should:

• Buy from a reputable supplier and always obtain an invoice

• Make sure the product/packaging is marked with the name and address of the
responsible person

• Ask to see proof that the product is safe (a copy of the cosmetic product safety
report)

The UK government provides further guidance on Placing manufactured goods on

the market in Great Britain - GOV.UK (www.gov.uk)