On February 29th, 2012, the U.S. Commercial Service will broadcast a webinar aimed at facilitating the U.S. cosmetic industry’s better understanding of the new European Cosmetic Regulation (1223/2009/EC) to repeal the EU Cosmetics Directive (76/768/EEC) on July 2013.
Obelis C.O.O, Doram Elkayam, will join the discussion on the new mandatory provisions of the EC Regulation, with a dedicated presentation on the EU Responsible Person and the New European Cosmetic Product Notification Portal (CPNP).
The webinar will cover central aspects of the new EU Cosmetics legislation, such as:
- General provisions of the cosmetic regulation with a comparative analysis on the safety requirements between the Cosmetic Directive 76/768/EEC and the New Cosmetic Regulation EC 1223/2009;
- The EU Responsible Person: roles and responsibilities;
- The New European Cosmetic Product Notification Portal (CPNP);
- The EU Safety Assessment (Toxicological Assessment): provisions & requirements;
- With a time for FAQs on labeling & language requirements, Nano-Materials, Product Information File, Safety Tests and more.
Join the webinar, Wednesday, February, 29, 2012 (17:00 pm CET) to discover everything you need to know about the new EU Regulations on Cosmetics!
The European Commission has recently issued a new Directive (Council Directive 2011/84/EU) regarding tooth whitening products, under which these are classified as cosmetics products. These were formerly classified as medical devices under the Medical Device Directive (MDD 93/42/EEC). The new Directive also makes reference to restrictions and conditions of use of hydrogen peroxide in teeth bleaching products.
According to the new Directive, only dental bleaching products with less than 0.1% hydrogen peroxide may be sold on the open market in the European Union. Furthermore, products having between 0.1%-6% hydrogen peroxide content may only be sold to dentists, while all other tooth whitening products with more than 6% hydrogen peroxide are forbidden in the European Union, as an additional measure on product safety for the European consumers.
As the NEW Cosmetic Regulation EC 1223/2009 on Cosmetic products implies, a correct label is the gateway to placing your product on the European market. The Label is one of the core elements within a cosmetic Product Information File (PIF).
As presented in our article on Official EU Languages & Labeling Requirements, labels shall be eligible, visible and contain certain obligatory mentions;
However, how to apply adequate labeling when facing impossibilities due to practical reasons?
For instance; how will all the necessary labeling information be presented in case of mascaras or eye pencils, where the packaging space, is simply too small?
Regulation 1069/2009 and Commission Regulation 142/2011 does not apply to finished products under the respective scopes of the:
- Scope of MDD 93/42/EEC
- Scope of AIMDD 90/385/EEC
- Scope of IVDD 98/79/EC
- Scope of Cosmetics under the 76/768/EEC and repealing regulation EC 1223/2009,
Since they are not considered as “animal by-products not intended for human consumption”. Therefore; they are not subjected to any veterinary checks under Council Directive 97/78/EC that lays down the principles governing the organization of veterinary checks on products entering the Community from third countries.
To review the complete analysis under our publication page – Click here;
While in the European market in reference to cosmetic products is regulated and harmonized by the Cosmetics Directive 76/768/EEC and the NEW Cosmetic Regulation EC 1223/2009, the regulatory framework in the USA has not been as comprehensive and stringent till today.
The current US law in effect is from 1938 and has not been amended ever since, therefore, a shift in the US cosmetic policy is indispensable. In light of the ongoing product safety concerns within the ‘self-regulated’ US Cosmetic industry, The Safe Cosmetics Act of 2011 was introduced on June 24th, 2011 to United States House of Representatives.
The first and foremost objective of this new Act is to eliminate the harmful chemicals from cosmetic products and require companies to fully disclose their product ingredients for the very first time. The most important features of the SCA is to reduce the loopholes deriving from its outdated status and to give the FDA the authority to see that personal care products are free of harmful ingredients.
The Introduction to EU Cosmetic Regulation tele-seminar took place on October 27th 2011, in association with the Indie Beauty Network (IBN) & Obelis European Responsible Person Center (O.E.R.P.C.).
The tele-seminar consisted of a brief overview of Obelis background, experience and expertise, the “main players” involved in EU cosmetic compliance, the steps to compliance, Product Information File, the necessity of appointing a professional “Responsible Person”, and much more. This was followed by an extended, open question and answer period. Members unable to attend the live seminar submitted questions to Donna Maria (IBN Founder) by email, Facebook, and Twitter.
After much anticipation, Obelis will be presenting an Introduction to the European Cosmetic Regulation in association with Indie Beauty Network to IBN Members placing Cosmetic products on the market on October 27th, 2011.
Do you know the basics of selling in Europe? Join in on the conversation.
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.
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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.