Notes on Regulations Governing the Export of Cosmetics

Background

The Regulation (EC) 1223/2009 on cosmetics has been applied in 27 EU member countries (plus Norway, Iceland and Liechtenstein) since July 11, 2013. It lays down a range of requirements on cosmetics placed on the EU market, covering the responsibilities of persons in charge and distributors, safety assessment, product documents, notification, the use of banned and restricted substances (and CMR substances), animal experiments, labelling and market supervision.

Cosmetics in the US market are regulated by the US Food, Drug and Cosmetic Act, Fair Package and Labelling Act and other regulations. These regulations stipulate the responsibilities of persons in charge and distributors, the requirements on the use of banned and restricted substances (especially colorants), labelling, safety assessment and market supervision. Some states (such as California) have local regulations concerning cosmetics. Products sold in these states should also conform to such regulations.

Scope

The definition of cosmetics varies across regions:

A cosmetic product is any substance or mixture intended to be placed in contact with the various 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 and/or correcting body odours and/or protecting them or keeping them in good condition.

- Regulation (EC) No 1223/2009

Cosmetics are articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance. Among the products included in this definition are moisturizers, perfumes, lipsticks, fingernail polishes, eye and facial makeup products, shampoos, perming products, hair colouring, toothpastes and deodorants, as well as any substance intended for use as a component of a cosmetic product.

- Federal Food, Drug, and Cosmetic Act

Products that require special attention are listed below:

Regulations

The EU

Responsible Person:

A legal or natural person in the EU must be designated as a Responsible Person (RP) for each cosmetic product placed on the EU market. The RP guarantees the compliance of the cosmetic product with relevant regulations. The RP may be the manufacturer, importer or distributor.

Safety Assessment, Product Information, and Product Notification:

Before placing a cosmetic product on the market, ensure a safety assessment is carried out, a safety report is drawn up and the product is notified in the Cosmetic Products Notification Portal (CPNP).

When placing a cosmetic product on the market, the RP should save and report the Product Information File (PIF) in electronic or other formats. The PIF should be kept at the address stated on the label for a period of 10 years following the date on which the last batch of the cosmetic product is placed on the market. The PIF should contain a description of the cosmetic product, a product safety report, a description of the manufacturing method, a statement on compliance with good manufacturing practice and proof of the effect or nature claimed for the cosmetic product.

Restrictions on Ingredients:

a)       Banned substances: The substances listed in Annex II to Regulation (EC) No 1223/2009 are prohibited for use in cosmetic products.

b)       Restricted substances: Restricted substances listed in Annex III, colorants listed in Annex IV, preservatives listed in Annex V and UV absorbers listed in Annex VI to Regulation (EC) No 1223/2009 should be used only when the conditions permit.

c)       Carcinogenic, mutagenic and reprotoxic (CMR) substances: CMR substances of category 1A, 1B, or 2 are banned for use in cosmetic products unless they meet the conditions laid down in Regulation (EC) No 1272/2008 CLP by way of exemption.

Labelling:

Cosmetic products should have a clear and recognizable mark containing the following information in a prominent position on the package:

a)       Name and address of the RP (country of origin for imported products)

b)       Nominal content at the time of packaging, given by weight or by volume, except for packaging containing less than 5g or 5ml, free samples and single-application packs; and product quantity for pre-packaged products.

c)       Date of minimum durability subject to Part 2 and 3 of Annex VII to Regulation (EC) No 1223/2009.

d)       Precautions for use, including at least the content in Annex III through VI to Regulation (EC) No 1223/2009 and precautions for professional cosmetics.

e)       Batch number or reference number which may be indicated on the outer package alone if the product is too small to display such information.

f)        Function of the cosmetic product

g)       List of ingredients

The US

Use of Banned Substances and Colour Additives:

• Banned substances: Nine substances listed in 21 CFR 700.11-21 CFR 700.35 are prohibited for use.
• Colour additives: Only colour additives listed in 21 CFR Part 73, 74 and 82 are allowed for use in cosmetics. Check if they are suitable to the area of body intended for application.

Labelling:

Cosmetic products should have a clear and recognizable mark containing the following information in a prominent position on the package:

a)       Product name (on the principal display panel)

b)       Net quantity of contents expressed in the terms of weight, measure, numerical count, or a combination of numerical count and weight or measure in oz, fl.oz, or lb within the bottom 30% of the principal display panel (except for special cases). Letter height should be adjustable to fit the principal display panel.

c)       Name and address of the company

d)       Composition marking

e)       Warning message (if any)

f)        Safe use instructions

Safety Requirements:

Ingredients and finished products must be proven safe before being sold.

Additional Requirements on Cosmetic Products in California:

Products sold in California shall conform to the following requirements in California Proposition 65:

a)       Lead (County of Alameda Court case No H217587 [consolidated with 01-032306]): no greater than 5 ppm in lipsticks and lip balms, and no greater than 10 ppm in eye shadows and blusher.

b)       Cocamide DEA (County of Alameda Case No RG 13 698427): prohibited from manufacturing, distribution and sale.

c)       1,4-Dioaxne: no greater than 10 ppm. A warning label must be attached to the product (soap and shampoo) if the amount of 1,4-Dioaxne is greater than 10 ppm.

Requirements for OTC cosmetics, i.e. products that meet the definitions of both cosmetics and drugs:

Some products have two intended uses. For example, anti-dandruff shampoo is both a cosmetic and a drug because shampoo is intended to clean hair while anti-dandruff agents are a drug intended to treat and control dandruff. Other examples include toothpaste with fluoride, antiperspirant deodorant, moisturizers and makeups with SPF.

The following information is not a complete treatment of cosmetic or drug laws and regulations. It is intended only to alert you to some important differences between the laws and regulations for cosmetics and drugs in the areas of approval, good manufacturing practice, registration and labelling. For specific regulations, refer to the Food, Drug and Cosmetic Act.

a)       Approval and registration: Cosmetics do not require pre-approval from FDA before marketing. They can be filed in the Voluntary Cosmetic Registration Program, 21 CFR 710 and 720 (VCRP) and do not need to provide the recipe list to FDA.

• Prior to marketing, drugs must be approved by FDA via an NDA pathway, or meet the regulations for special categories stipulated by FDA's OTC drug review agency. The drug formula should also be submitted to FDA.
• Separate regulations for OTC drugs cover a range of drugs including drugs treating acne, dandruff, seborrheic dermatitis and psoriasis, and sunscreens.

b)       Good manufacturing practice: FDA provides guidance on GMP for cosmetics but no specific regulations. Drugs shall strictly adhere to the current GMP (cGMP) and the minimum requirements stipulated in 21 CFR 210 and 211.

c)       The labelling of OTC drugs must comply with the regulations for OTC drugs, including "drug information" marking (21 CFR 201.66). If a product is both an OTC drug and a cosmetic, its labelling must comply with the regulations for both OTC drug and cosmetic labelling. For example, the drug ingredients must be listed alphabetically as "Active Ingredients", followed by cosmetic ingredients, listed in descending order of predominance as "Inactive Ingredients".

Good Manufacturing Practice of Cosmetic Products (GMPC):

Good Manufacturing Practice (GMP) Guidelines/Inspection Checklist for Cosmetics, revised in April 2008, is a set of guidelines in aspects of equipment, personnel, raw materials, production, laboratory controls, records, labelling and complaints. These guidelines help manufacturers apply appropriate infrastructure and production equipment, appropriate manufacturing process and sound quality management and inspection system to ensure that the final products conform to applicable regulations and will not be considered adulterated and mislabelled. These guidelines also help reduce the risks of recalls and ensure traceability of products.

Legal Basis

For more information about cosmetics regulations, please refer to:

• EU Cosmetics Regulation
• Cosmetic product notification portal
• US FDA cosmetics regulation website
• Code of Federal Regulations Sections for Cosmetics Labeling
• Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?)

Note: The above information does not constitute any legal advice and shall not be deemed or represent the legal opinion or conclusion of the regulatory body. Further, we do not undertake or warrant that the information represents the latest laws and regulations. For specific information, consult the competent authority, law firms, or third-party certification/testing/consulting companies in the target country or region.
 

AliExpress
August 31, 2020