Pharma D&S





On July 11th 2013, the regulation (EC) n. 1223/2009 on cosmetic products will fully replace directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products. Therefore the regulation of the cosmetic field in the European Union is going through a transitional phase, by passing from the Council Directive 76/768/EEC (implemented in Italy by the Law October 11th 1986, n. 713), to the European Regulation 1123/2009, already in force as from January 1st 2010, providing an implementation by steps: some of these steps have been already started up, whilst other will be set up in the next months, to become fully operative starting from July 11th 2013.

As a consequence, this transitional phase covering the period ranging from January 1st 2010 to July 11th 2013, is governed by Directive 76/768 still in force, but concomitantly also the marketing of products that, for some aspects, comply with the new Regulation, is allowed.

The new Regulation provides a stricter definition of some aspects and standardizes the legislation for the whole European territory, in particular as concerns:

• Electronic European Notification

• Observance of Good Manufacturing Practices

• Product Information File

• Safety Report and information on the safety director

• Ingredients subject to restrictions

• Use of CMR ingredients (classified as carcinogenic, mutagenic or toxic for reproduction)

• Nanomaterials

• Statements relating to products (claims): definition of the Commission of cogent common criteria

• Specific obligations for people responsible for marketing and for distributors

• Obligation to notify serious adverse events



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