On 11 July 2013 the new EU Regulation 1223/2009 - ‘EU Cosmetics Regulation’- came into force replacing Directive 76/768/EC (that was adopted in 1976.)
Article 8.1 of the EU Cosmetics Regulation requires that ‘Manufacturing of cosmetic products shall comply with good manufacturing practice’.
Furthermore, article 8.2 states: ‘Compliance with good manufacturing practice shall be presumed where the manufacture is in accordance with the relevant harmonised standards…’
From July 11, 2013, the new ISO 22716 standard for Cosmetics Good Manufacturing Practices (GMP) takes full effect and becomes mandatory for cosmetic companies across the EU.
To ensure consumers’ safety all cosmetics products coming onto the European market will have to be produced according to the Cosmetics Good Manufacturing Practices described by the ISO 22716 standard.
At the moment there is no need to get approval/certification from any external bodies/organisations to say you comply with this standard. As stated in the EU regulations it is assumed that you are, and you will be in breach of the regulations if you are not.
Established cosmetic makers may be compliant with ISO 9000. There are many similarities between this ISO and the ISO 22716 but ISO 9000 compliance is not a guarantee that you will meet the requirements of ISO 22716.
Cosmetic GMP is a set of hands-on advice referring to all activities that can affect the quality - and therefore safety - of the final product. It includes operational rules and organisational guidelines for the production, control, storage and shipment of cosmetic products. It states general requirements for manufacturers of cosmetic end products according to the equipment, production facilities, inputs, control of hygiene, production, hygiene requirements for personnel, laboratory control, labelling, monitoring of complaints and product recalls.
Guidelines covered by the GMP ISO 22716 are intended as a general guideline for the manufacturers to develop their own internal quality management system and procedures
Key elements of ISO 22716 include:
• Personnel and training
• Raw materials and packaging
• Production / Manufacturing
• Finished product
• Quality control and sample retention
• Subcontract operations
• Complaints and recall
• Change control
• Internal audit (continuous improvement)
As mentioned above the certification is not compulsory and ISO 22716 despite being mandatory is only a set of guidelines – thus leaving us ‘space’ for subjective application. While working from home will not be the same as having a dedicated production plant you are legally obligated to do your best under the circumstances e.g. apply stringent measures to ensure hygiene, precise weights and measures, pH control, correct documentation and waste disposal – only the highest standard of any aspect of your operation is expected and must be implemented. (Reminder: Trading Standards can check on your hygiene and scales, waste disposal, etc.)
This on-line course not only makes the GMP guidelines for small cosmetic makers simple but it also provides some examples of the various documents that will need to be created by manufacturer in order to satisfy these legal requirements. It also explains in simple language the necessary steps that must be undertaken to ensure compliance with the new regulations.