Other services
BIORIUS also assists in:
The cosmetics, personal care & toiletries sector
For finished products:
Label review for the EU
Product Information File (“Dossier”) review for the EU
For ingredients:
Compliance with the EU REACH regulation
The food supplements sector
Food supplements in the EU
Food supplements outside the EU
THESE SERVICES ARE DETAILED BELOW.
Cosmetics, Personal Care & Toiletries
FINISHED PRODUCTS
LABEL REVIEW FOR THE EUROPEAN UNION
To place cosmetic products on the EU market, the container and packaging must bear a series of information in indelible, easily legible and visible lettering:
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the name or style and the address or registered office of the manufacturer or the person responsible for marketing the cosmetic product who is established within the Community
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the nominal content at the time of packaging
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the date of minimum durability
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particular precautions to be observed in use
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the batch number of manufacture or the reference for identifying the goods
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the function of the product
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a list of ingredients
Cosmetic products labels and packaging can be reviewed by BIORIUS to check compliance with Article 6 of the EU Cosmetics Directive.
PRODUCT INFORMATION FILE REVIEW FOR THE EUROPEAN UNION
The person responsible for placing an imported cosmetic product on the EU market must for control purposes keep specific detailed information readily accessible to the competent authorities of the Member State concerned at the address specified on the label.
The data required in the product information file (PIF, sometimes called “Dossier”) can be reviewed by BIORIUS to check compliance with Article 7a of the EU Cosmetics Directive.
INGREDIENTS
COMPLIANCE WITH EU REACH REGULATION*
REACH is a new European Community Regulation on chemicals and their safe use (Regulation EC 1907/2006). It deals with the Registration, Evaluation, Authorisation and Restriction of Chemical substances.
The REACH Regulation was developed and adopted to fill the information gaps to ensure that industry is able to assess hazards and risks of the substances, and to identify and implement the risk management measures to protect humans and the environment.
It gives greater responsibility to industry to manage the risks from chemicals and to provide safety information on the substances. Manufacturers and importers will be required to gather information on the properties of their chemical substances, which will allow their safe handling, and to register the information in a central database.
*Source: European Commission REACH website.
Food supplements
IN THE EUROPEAN UNION
The cosmetics, personal care & toiletries industry in the European Union is governed by the European Commission's Directorate General for Health and Consumers.
The legal framework set for regulating this sector is the EU food supplements Directive ( 2002/46/EC ).
It defines food supplements as "foodstuffs that are concentrated sources of nutrients or other substances with a nutritional or physiological effect, alone or in combination, marketed in dose form, whose purpose is to supplement normal diet."
A company wishing to market a nutritional product across Europe must comply with EU and national laws and a range of evolving market practices. The specific technical and regulatory guidance needed for negotiating the existing EU maze to get food supplements marketed in the EU Member States can be performed by BIORIUS.
OUTSIDE THE EUROPEAN UNION
For markets located outside the European Union, each country or region follows a particular legal framework. BIORIUS also assists in placing food supplements on a non EU market and will address each country on a case by case basis.