The Legislation concerning Food Supplements is composed of a number of Communityand National rules defining and governing a range of products that, besides meeting the General Food Law, should also refer to more specific rules.
- Management of Regulatory Affairs
- Assessment of the Regulatory compliance of food supplement composition
- Preparation of the Technical Documentation
- Request for a claim authorization
- Product Labelling and Advertising claims
- Clinical Trials
In the EU, the Biocidal Products Regulation (BPR) refers to Regulation (EU) 528/2012 concerning the placing on the market and use of biocidal products. It repeals the Biocidal Products Directive (Directive 98/8/EC) and comes into force on 1 Sept 2013.
The key requirement of BPR regulation is that all biocidal products require an authorisation by European Chemicals Agency (ECHA) before they can be placed on the EU market, and the active substances contained in that biocidal product must be previously approved.
Even if It is now more than six years since the BPR came into force, the European legal framework for biocides is still proving challenging and dynamic with new issues flaring up as others are resolved and national approval procedures are still in place.
- advice you on current Italian and European regulations and on the evolution of legislation on biocides, in particular on the Presidio Medico Chirurgico-biocides transition period
- check the active substances of a formulation in order to classify the product as biocide / free-selling product or other according to European and Italian regulations (feasibility study);
- evaluation and revision of the available documentation according to the current regulations to apply for authorisation, preparation of the application, submission and follow-up
- set-up assistance, presentation of the registration dossier with the competent Authorities and related authorization procedure for a PMC;
- assistance in preparing dossiers for PMC production authorization and related authorization procedure at the Italian Ministry of Health;
- translations of texts and labels from / to the following languages: Italian, English, Spanish, French, German;
- elaboration and mock-ups of labels;
- support in the switch from PMC (“Presidio Medico Chirurgico”) to biocide: documents revision, submission to the authorities and procedure management, including support to answer the comments received by the authorities
- contacts with Regulatory Authorities
- quality management
Regulation (EC) N° 1223/2009 on cosmetic products is the main regulatory framework for finished cosmetic products when placed on the EU market.
The most significant changes introduced by the cosmetics regulation include the need for the manufacturers to follow specific requirements in the preparation of a product safety report prior to placing a product on the market and to have a ‘responsible person’ within the EU. A precise identification of the responsible person and of their obligations are detailed in the Regulation. Moreover, the regulation defines the obligation to notify serious undesirable effects to national authorities.
- Revisioning of labelling
- Vigilance services
- Contacts with Regulatory Authorities
- Advice on cosmetics regulation
- Notification to the Italian competent authorities
- Translations of texts and labels from / to the following languages: Italian, English, Spanish, French, German;
- Elaboration of mock-ups of labels.
- Quality Support (SOPs, system management, Third party Audits)