Austria Cosmetic Product Registration

COSMETIC REGISTRATION IN AUSTRIA Regulatory Authority

• Austrian Agency of Health and Food Safety

Link for RA:

http://www.ages.at/

• The manufacturer (either a natural or legal person) who directly produces a cosmetic product, or who has it manufactured or developed and markets it under their own name or brand.
• The importer.
• In specific situations, the distributor.
• A person within the EU, to whom the manufacturer, importer, or distributor delegates responsibility through a written mandate.

• Safety – Cosmetic products are required to ensure human health safety during normal or reasonably anticipated usage.
• Notification – Cosmetic products must undergo electronic notification to the Commission before their introduction to the market.
• Manufacturing Compliance with Good Manufacturing Practices – Cosmetic products must be manufactured in accordance with Good Manufacturing Practices.
• Creation and Maintenance of Product Information File and Safety Assessment – Responsible parties are mandated to establish and uphold the product information file and safety assessment protocols.
• Control of CMR Substances and Prohibited Substances – Cosmetic products are prohibited from containing CMR substances.
• Nanomaterials – Cosmetic products containing nanomaterials must undergo electronic notification to the Commission six months prior to market placement, in addition to the standard notification under
• Labelling and Advertising Claims – Cosmetic products must adhere to specific labelling requirements, and advertising claims must be accurate and compliant.
• Reporting Serious Adverse Reactions – Any serious adverse reactions related to cosmetic products must be reported.
• Public Information on Composition and Undesirable Effects – The public must be informed about the qualitative and quantitative composition, as well as any severe undesirable effects, of cosmetic products.

The product information file comprises the following information, presented in a language easily understood by the responsible authority of the respective member state (typically in German):

• Description of the cosmetic product
• Safety report
• Manufacturing method adhering to good manufacturing practices.
• Evidence substantiating advertised effects.
• Records of conducted animal experiments.

The responsible person is required to ensure easy accessibility of the product information file to the competent authority, either electronically or in another format, at the address specified on the product label. This file must be created and regularly updated for each individual cosmetic product available on the market. It should be retained for a period of ten years after the last batch of the cosmetic product was introduced to the market.

The safety report, as stipulated in Article 10 and Annex I, is a fundamental component of the product information file. It must be collaboratively prepared by the safety assessor and the responsible person prior to the cosmetic product’s market placement. This report consists of two main sections:

Safety Information: Encompassing all crucial characteristics of the cosmetic product and its ingredients relevant to product safety, including:

1. Product composition 

2. Physical and chemical properties, along with stability

3. Microbiological quality

4. Contamination, traces, and packaging materials

5. Normal and foreseeable usage scenarios

6. Exposure to the product and its constituent substances

7. Toxicological profile of the ingredients

8. Documentation of any (serious) adverse effects

Safety Assessment: Justifying the safety of the cosmetic product based on the data presented in the safety report, supplemented with any necessary warnings if required.

Labelling

According to Article 19, paragraph 1 of Regulation (EU) 1223/2009, the following details must be prominently displayed, in a manner that is easily readable, permanent, and clearly visible, on both the packaging and the container of the cosmetic product while also accounting for specific exceptions:

• Name and Address
• Nominal content
• Durability
• Special precautions for use
• Batch number
• Purpose of use
• Components