COSMETICS - EN ISO 22716: 2008 (GMP) ASSISTANCE IN CERTIFICATION
In December 22, 2009 was the EU Official Journal published the new 1223/2009 Regulation on Cosmetics to replace the Directive 76/768 / EEC for the regulation of production and sale of cosmetic products.
The harmonized standard that describes the GMP (Good Manufacturing Practice) requirements specific for the cosmetics sector is UNI EN ISO 22716: 2008 "Cosmetics - Good Manufacturing Practices (GMP) - Guidelines on Good Manufacturing Practices Guide".
This document, designed specifically for the cosmetics industry and thus elaborated on the specific needs of this sector, provides the guidelines for the production, control, storage and shipment of cosmetic products.
By 13th July 2013, the compliance with the GMP requirements will be binding and the adoption of harmonized standard EN ISO 22716: 2008 will be the way to demonstrate compliance (Article 8).
Purpose of the Regulation is to simplify procedures and facilitate the market control, in order to ensure a high level of protection of human health.
The new Regulation provides that production and packaging of cosmetic products are made in accordance with standards of good manufacturing practice in order to ensure the achievement of the Article 1 of the Regulation objectives.
Where manufacturing is in accordance with the relevant harmonized standards, which references were published in the EU Official Journal, compliance with good manufacturing practice is assumed.
For this reason, the responsibility of the manufacturer and the market control have been increased through:
- The duty of adoption of good manufacturing practices;
- The guarantee of transparency and objectivity in information accompanying the product;
- The definition of shared and harmonized rules, valid in all EU countries, to facilitate market surveillance and improve efficiency;
- The traceability of a cosmetic product throughout the supply chain, to combat trademark counterfeiting.
MAIN NOVELTIES OF THE EC 1223/2009 REGULATION
Set of definitions (Article 2)
- It was added a set of definitions which was absent. By way of example, we can mention to the importance of the definitions of “introduction”, and “made available on the market”, on the manufacturer’s market or the distributor’s market who over the years had given rise to a heated interpretation debate;
Evaluation of the safety of cosmetics (Article 10)
- Previously there were not specified the information that the safety assessment should contain. Now the crucial element of the new text is the clarification regarding the information to be contained in the safety assessment of the cosmetic product.
centralized notification (Article 13)
- In accordance with the objective of harmonizing the various national rules on the placing on the market procedure, there is provided a centralized and electronic notification to the European Commission containing a series of predetermined information. At time of market release, it is expected to always send to the Commission the label and a photography of any product.
CMR substances (Article 15)
- Until now, CMR 1 and 2 substances were automatically banned in cosmetic products. CMR 3 substances were banned unless the Scientific Committee, on the basis of the exposure data, not conclude that the substance is safe for use in cosmetic products. Article 15 intends to propose a risk management system for CMR 1A or 1B substances - according to Annex VI, Part 3 of the Regulation (EC) No. 1272/2008 - e2 which allows, subject to rigid conditions, the use of these substances if they have been found safe by the Scientific Committee on Consumer Products (SCCP).
Nanomaterials (Article 16)
- For products containing nanomaterials, there is provided a notification that also contains a range of information about the same nano materials: the size of particles, physical and chemical properties, an estimate of amounts that are expected to enter the market for year, the toxicology profile, safety data and the reasonably foreseeable exposure conditions which must be submitted six months before market release. In addition, the list of ingredients shown on the cosmetics packaging must clearly show the presence of nanomaterials. Within 48 months after entry into force of the Regulation, the Commission will make available a catalog of all nanomaterials used in cosmetic products put on the market.
Labeling
- In the label of cosmetics, should not be used text, names, trade marks, images or other signs, figurative or not, "that attribute to those products characteristics or functions which they do not possess." As requested by Members of the European Parliament, the Commission will also have to establish an action plan in cooperation with Member States, regarding claims appearing on cosmetics and fix priorities in determining common criteria justifying their use. It will then have to adopt a list of common criteria for claims which may be used on cosmetic products.
Market surveillance (Article 22)
- Member States should carry out controls on products and economic operators, conducted on an adequate scale, through the product information file and, where appropriate, physical and laboratory tests, based on adequate samples. They will then have to ensure respect for the principles of good manufacturing practice and provide the market surveillance authorities with the skills, resources and knowledge necessary to enable them to carry out their tasks adequately. Finally, to help simplify market surveillance and to improve efficiency, It will be necessary to ensure the traceability of a product throughout the supply chain.
The ISO 22716: 2008 is the first international reference document that provides guidance for a GMP management in the cosmetic companies and represents a significant contribution to to raise the safety of the cosmetic sector.
But what is its purpose and its scope?
"The ISO 22716 shall apply to the production, testing, storage and shipment of cosmetic products to guarantee the consumer high standards of safety and sanitation."
But they are focused on the quality aspects of the product and does not cover aspects of environmental safety, corporate responsibility and local regulations. Also exclude research and development and distribution of finished products.
ISO 22716:07 has a correspondence with the ISO 9001:2008, the generic quality standard that applies to any kind of company, that's why those who are ISO 9001 certificate more easy are able to demonstrate compliance with ISO 22716:2008
"The certificate of quality ISO 22716: 2008 provides the impartial evidence, as issued by a third-party body, that the company has a GMP system and applies it.
A very good tool not only to monitor the production process but to make visible to the consumer the company commitment to work in accordance with a recognized standard at international level."
And that's not all. "We report, in fact, that the EFfCI (European Federation for Cosmetics Ingredients) has drawn up, based on existing good manufacturing practices developed in the pharmaceutical industry, a guideline for the application of GMP even in companies producing raw materials. An indispensable tool to avoid that the benefits of implementing a GMP system are reduced if not negated. " You also require a preliminary verification to assess the state of compliance of the company with regard to the ISO 22716:07 and EFfCI requirements Guidelines and, therefore, identify areas for improvement and strengths.
Bio Chem srl develops Innovative Quality-based systems on the concept of “Risk Based Approach" able to determine a soft revolution in your production operations, without significant increases in resources to be allocated in the budget. Our professionals have the know-how necessary for gradually managing the type of transition from ISO quality system phase to that type GMP.
The Good Manufacturing Practices operationally describe the activities to undertake on the basis of more general concepts of quality assurance, with the advantage of adopting procedures simplified and shared in all EU countries, so ensuring greater market control.
With the certification of compliance with UNI EN ISO 22716: 2008, companies have the ability to:
- Ensure compliance to regulations on Good Manufacturing Practices for cosmetic products;
- Integrate the certification with the ISO 9001: 2008 Quality Management System with a more specifically sectoral approach;
- Give certainty to stakeholders, customers, distributors, importers, and consumers, that the production is carried out in accordance with Good Manufacturing Practices.
Bio Chem srl according to EN ISO 22716: 2008 (GMP):
- Review the organization's production state of the art and the impact of activities to be implemented to achieve compliance with GMP by means of pre audit activities;
- Assist the company in obtaining EN ISO 22716: 2008 (GMP) certification that provides for the issuance of the certificate of conformity. The certificate of conformity will enable companies to meet the requirement set by the European Regulation of cosmetic products;
- Performs setup of the documentation system;
- Performs the writing of GMP manual and operational procedures to support the production process management, control, storage and shipment of cosmetic products.
