The Responsible Person serves as the focal point for all necessary undesirable effect and serious undesirable effect communication. This includes contact with manufacturer, raw material supplier, importer, distributor end user, cosmetics professionals, health professionals, and the Competent Authorities. Effective communication is necessary in situations of serious undesirable effects which must be reported to all entities in contact with the product, as well as to the Competent Authorities where the effect occurred.
This notification of undesirable effects follows a set of guidelines which includes a causality assessment method, a report form and exchange of information between member-states authorities and the European Commission. The Responsible Person must handle all necessary communication immediately when an incident or crisis occurs.
Evidence on Good Manufacturing Practice (GMP) is one of the essential requirements of the EU Cosmetic Regulation in Europe (EC 1223/2009) in light of product placement onto the European market. The GMP is only in reference to the entity which actually produces the product (the Producer). However, any entity placing cosmetic products onto the EU market under its name is required to have evidence of GMP (in reference to its Producers) as part of their Product Information File (PIF).
The producer may show evidence of GMP by obtaining a third-party certificate in reference to an on-site audit or they may issue a signed declaration which states they meet the criteria for Good Manufacturing Practices. One specific way to ensure the producer provides sufficient evidence is through the ISO 22716 standard which was adopted as a CEN standard (a European Standard). European regulation directs that the CEN/ISO Norm 22716 serves as presumption of conformity towards GMP.
| Home | Contact Us | Get a Quote |
Summary of the Guidance Document:
The “Guidance Document of the Demarcation between the Cosmetic Products Directive 76/768/EEC and the Medicinal Products Directive 2001/83 as agreed between the Commission Services and the Competent Authorities of the EU Member States” document attempts to provide guidance for the classification of products that may simultaneously fulfill the definition of a cosmetic product (as per the 76/768 Directive) as well as the definition of a medicinal product (as per the 2001/83 Directive).
EUCORE 5 is organized by Obelis European Authorized Representative Center (O.E.A.R.C.) together with the Federation of Israeli Chambers of Commerce and the full support, guidance & involvement of the Israeli Ministry of Health.
EU Market Timeline:
1. The European Community (1957)
2. Schengen Visa area (1985)
3. Unified European Market (1992)
4. “New Approach” (1985,1989,1993 & 2010)
5. The Euro born (2002)
According to EN ISO 22716 on Cosmetics — Good Manufacturing Practices (GMP) — Guidelines on Good Manufacturing Practices Article 12 – Subcontracting.
The GMP certificate is to be issued only to the producer (the one which actually produces the cosmetic products) and not to the manufacturer as it can be that a manufacturer does not actually produce anything (only owns the bands) hence there is nothing to certify.
The manufacturer will be required to properly document in its PIF (Product Information File) the evidence that his producer has obtained a GPM certificate for the production of his cosmetic products – that is sufficient in regards to the conformity with the NEW EC 1223/2009 European Cosmetic Regulation (and 76/768/EEC Directive).
Obelis has launched its new International Offices and will be hosting EROMED at its home offices in Brussels, Belgium.
EROMED is a 2 day workshop exclusively aimed at Obelis International Offices (O.I.O) network – providing regulatory updates, knowledge & expertise and promoting Obelis European Authorized Representative Center (O.E.A.R.C.) services in their global markets.
The Workshop is organized by Obelis s.a European Authorized Representative Center & GiDoS s.p.r.l in association with INTERTEK. Presentations will be given by experts in their fields about the latest developments in the European Regulatory framework concerning Medical Devices, In-Vitro Diagnostics, Cosmetic products, and others, with a special emphasis on the recent implementations of the 2007/47/EC, as of March 21st, 2010 (MDD), and the EC 1223/2009, as of November 30th 2009 (Cosmetics).
The EN/ISO/ 22716 guidelines are intended to provide guidance regarding Good Manufacturing Practices for cosmetic products. These guidelines have been prepared for consideration by the cosmetic industry and take into account the specific needs of this sector. These guidelines offer organizational and practical advice on the management of the human, technical and administrative factors affecting product quality.
Professional Seminar on: The New European Regulation on Cosmetics
The EUCORE seminar is a unique opportunity for importers of cosmetics to be exposed to European demands by European experts (e.g. representatives of the Belgian Ministry of Health and from the British Toxicology Lab INTERTEK) in light of the Israeli Ministry of Health will for alignment of the Israeli Law with the European regulation.
As such, Obelis European Authorized Representative Center (O.E.A.R.C) in association with the Israeli Chamber of Commerce, the Manufacturers Association of Israel, The Israeli Society of Chemists and the Cosmetics Division at the Ministry of Health have taken it upon themselves to organize this special event.
Obelis European Authorized Representative Center (O.E.A.R.C ) in Cooperation with the Manufacturers Association of Israel (the Cosmetic Department) and the Israeli Ministry of Health (Pharmaceutical Division) are proud to introduce the “EUCORE” Workshop aimed at the “New European Cosmetic Regulation – Provisions and Implementation”.
The workshop will be a one-time opportunity dealing with the requirements of the European Cosmetics regulation by European Experts in light of the Israeli Ministry of Health desire to harmonize and align its regulation with the European regulation.