On April 21, 2011, the EU Official Gazette published the "EN ISO 22716:2007 Cosmetics - Good Manufacturing Practice (GMP) - Good Manufacturing Practice Guidelines" (ISO 22716:2007), announcing that the Guidelines formally become the EU Cosmetics Code (EC) No 1223/2009 GMP coordination standards, that is, in line with EN ISO 22716:2007 that is to say, compliance with EN ISO 22716:2007. GMP requirements for EU cosmetic regulations. The first EU cosmetics regulation (EC) 1223/2009 was formally implemented as a national law in 27 EU member states (as well as Norway, Iceland and Liechtenstein) on July 11, 2013, unlike previous Cosmetics Directive 76/768 EEC, which required conversion before implementation in each country. The regulations put forward more stringent requirements on the safety of cosmetics, which clarified that the person responsible for the product will bear more legal liability, EN ISO 22716 is also in line with the new EU Regulation (EC) 1223/2009 involving GMP requirements.
The International Cooperation on Cosmetic Regulation (ICCR) is an international organization composed of the Food and Drug Administration of the United States, the Ministry of Health, Labor and Welfare of Japan, the General Directorate of Enterprises of the European Commission of the European Union and the government cosmetics regulatory authority of the Canadian Ministry of Health. ICCR held second meetings in Washington, D.C. in July 2008. At the meeting, regulators of various countries agreed to implement the ISO 22716 standard in their respective regions as far as possible. The specific situation is as follows: the United States agreed to consider ISO 22716 international standards and modify the existing FDA guidelines. The EU will implement the international standard TC 217/ISO 22716 adopted by the European Committee for Standardization (CEN). Canada agreed to consider the ISO 22716 international standard and looked forward to adopting the voluntary GMP standard of ICCR-3. Japan informed local governments that the Japan Chemical Industry Association (JCIA) adopted ISO 22716 international standards.
Challenge
With the rapid development of social economy and people's living quality, the import and export trade of cosmetics is growing rapidly. With the development of cosmetics industry, the technological content of products is increasing and the quality is improving continuously, the export trade of cosmetics will have a greater development.
Accompanied by this, cosmetics enterprises will face increasingly severe export competition pressure challenges, cosmetics enterprises are increasingly required not only in the brand influence but also in product quality control. Foreign cosmetics brands have stricter requirements on the factory, generally on the factory hardware, facilities, health, personnel and management system has strict requirements. Therefore, the ISO22716:2007 International Standard Certification of Good Cosmetic Production Standard will gradually develop into a new trend of cosmetic export standards. Through this certification, the management level of cosmetics will be greatly improved, and the products will also play a good role in promoting the entry into the international market.
primary coverage
The terms and conditions of ISO22716
1. scope of application
2. terms and definitions
3. personnel
4. workshop
5. equipment
6. management of raw materials and packaging materials
7. production process
8. finished products
9. quality management laboratory
10. specification for external products
11. discarded
12. subpackage
13. differences
14. complaints and recalls
15. change management
16. internal audit
17. document management
Specific requirements of ISO22716
Personnel: Employees must have good personal hygiene and health conditions, all staff to carry out skills training, training should be assessed after the accumulation of staff knowledge...
Workshop: Workshop site selection, design, structural use should ensure the protection of products, reduce the cross-mixing of products, raw materials, packaging materials; storage, production, quality control in the designated area and provide adequate space for goods reception, storage, production and so on.
Equipment: Should meet the expected use and easy to clean, if necessary, disinfection and maintenance, maintenance work can not contaminate the product...
Production: At each stage of manufacture and packaging, measures shall be taken to ensure that the finished product conforms to its proper characteristics; all manufacturing processes shall be carried out in accordance with the requirements of production documents, and process validation and process control are required...
Disposal of non-conforming products: The authorized personnel shall analyze and study the rejected items, control the reworked products and have the authorized personnel inspect them to verify their conformity.
Complaints and recalls: All complaints returned to the factory should be reviewed, investigated and followed up; in the event of a recall affecting consumer safety, authorized personnel should be given the power to let everyone know...
In short, ISO22716 is aimed at the characteristics of cosmetics manufacturers plant equipment, personnel, plant management and control of software and hardware made specific requirements.
Implementation advantages
- ensuring product safety
- improving product quality management level
- Reduce the risk of injury or death to consumers and protect the safety and health of consumers
- elimination of dangerous accidents
- reduce the risk of product public recovery.
- effective control of costs and international recognition.
- enhancing product competitiveness
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