Scope of the Law

For the first time, manufacture, packaging, distribution and trade of cosmetic products will be regulated. The law applies to all cosmetics products manufactured industrially and placed in the Albanian market.

Cosmetics include all products ranging from everyday hygiene products such as soap, shampoo, deodorant, and toothpaste to luxury beauty items including perfumes and makeup. They should be safe for the health of people taking into account in particular the following elements:

• their external look that should be easily distinct from food products;
• labeling;
• use instructions;
• any other indication or information provided from the Responsible Person.

Responsible Person

The person or company that places the cosmetic product in the market is responsible for that product (the so called ‘Responsible Person’) and it must ensure that the product is safe and meets all the requirements of the law. The Responsible Person must be an entity or person registered with the Albanian commercial registry i.e. National Registration Centre, hence it can be the manufacturer, distributor or importer of the product registered for business in Albania.

Key obligations of the Responsible Person are:

• Corrective Measures: The Responsible Person must take the necessary corrective measures in case if finds out that a cosmetic product placed in the market does not meet the requirements of the law, by recalling or stopping the trade of the product, as applicable. In case the product is dangerous for the public health, the ministry of health must be informed in which case in which case actions for recall of the product must be coordinated with the ministry.

• Safety Evaluation: Before placing a product in the market, the Responsible Person must ensure that the product has been subject to safety evaluation based on the forms and reports approved by the ministry of health. Only qualified persons with background pharmacy, medicine or similar disciplines can make the safety evaluation.

• Product File: Obligation to prepare and keep the cosmetic product information file is a key feature of the law. The Responsible Person must keep a product file for each product placed in the market for 10 years from the last date that the product was placed in the market. The information in the file should include: a) a description of the product; b) the safety evaluation report; c) the manufacturing methods and good practice compliance declaration; d) animal testing information, etc. The product file must be made available to the ministry of health in English or Albanian.

• Notification of the ministry of health: Before a product is placed in the market, the Responsible Person must electronically provide certain information to the ministry of health in relation to the category of the product, the Responsible Person contact details; origin of the product; nanomaterials presence in the product; possible exposure conditions; name of certain dangerous substances, etc. After the product is placed in the market, the original label and picture of the product must be also sent to the ministry.

Consumer Protection

The law sets out detailed obligations on the labeling of cosmetic products. Noteworthy, the label of the product must be in Albanian language. It must include inter alia information on the Responsible Person, origin of imported products, expiry date, volume or weight of product, instructions for use, production lot date, function of the product, ingredients, etc.

The Responsible Person must secure access to qualitative and quantitative information of the product to interest persons, subject to restrictions for the protection of commercial secrets and IP rights.

Market surveillance and administrative penalties

The Ministry of Health inspectorate is responsible for the enforcement of the law.  Non-compliance with the law can be sanctioned with fines ranging from 100.000 to 500.000 LEK (approx. 700 – 3500 EUR) and confiscation of the cosmetic products.

When to be ready?

Cosmetic products businesses are not caught unprepared. The legislator has given enough time to the business to make their trade compliant with the new regulations i.e. one year after the law enters into force.

Unquestionably, the enactment of this law is expected to improve not only the quality of the products that are place in the market but on the same time will help consumers choose what is best for them.