cosmetic regulation

Safely and carefree

in cosmetic industry

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EU REGULATION

TESTING

UK REGULATION

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of easy&carefrEe

in cosmetic regulation

Cosmetic regulation in form of one stop shop. Our vision is to be customers guidance on every step of the way to the European and UK market. Becoming one of the main companies helping customers to their breakthrough on the EU and UK market is our mission. With our team of professionals, we are on a good path of achieving our set goal. Start now and finish with only 5 steps.

assessed products
different countries
notified products

Why our team of cosmetic regulation experts is the best for you?

Short lead time

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Experienced team

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What Our customers say

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cosmetic regulation

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I have a product and all documentation.

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Location

Ulica Ivana Hribarja 22, 4207 Cerklje na Gorenjskem, Slovenia

Our hours

7:00 AM – 15.00 PM
Monday – Friday

Contact us

Phone: +386 40 331 130
Email: office@burstein-eu.com

From the heart of Europe to you!
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Our main concern is to guide you on the way to selling cosmetics on the European market. As experts in cosmetic regulation we provide support for cosmetic industry in Regulatory Affairs, GMP’s, we help you to development new products from idea to placing on the market and help you by checking your products documentation, claim support check-up, labelling guidelines, tests, performing Cosmetic Product Safety Reports and Product Information File preparation, cosmetovigilance, notifying products into European cosmetic online system (CPNP) and acting as a responsible person for your products.

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    QUESTIONS?

    We give you answers.
    • 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.

    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.

    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.
    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’.

    cosmetic regulation

    We drive you across the rapids to the finish line

    office@burstein-eu.com

    +386 40 331 130