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 globe. The European Union’s new regulation, EC No. 1223/2009, replaces the Cosmetics Directive, 76/768/EEC, that required cosmetic products to be manufactured according to the GMP and which has been adopted by the USA, European Union (EU), Canada and Japan.

The EU regulatory framework states that “in accordance with the relevant harmonised standards”, the manufacture of cosmetic products shall comply with the principles of GMP; and cosmetic products “must be safe” when used under normal or reasonably foreseeable conditions.

The Cosmetics Directive 76/768/EEC defined the safety criteria to which cosmetic products must conform and prescribed rules for their labelling and packaging. Over 30 years later on December 22, 2009, the directive was recast as the Cosmetic Products Regulation (EC) No. 1223/2009, which entered into force on January 11, 2010 and takes full effect from July 11, 2013.

All cosmetic manufacturers, importers, exporters and distributors require cosmetic products on the EU market to be proven, i.e. that they have met the requirements of GMP and demonstrated compliance to the associated standards. Thus, it is key for all stakeholders in the cosmetics industry to understand, meet and comply with the new requirements and regulations. Work to start mapping existing products to meet this new requirement should have begun, in order to avoid any loss of market approval.

Good Manufacturing Practice (GMP)

Cosmetics GMP is a set of hands-on advice, operational rules and organisational guidelines focused specifically on human, technical and administrative factors affecting product quality. The objective of the GMP is to define the activities which lead to the final product corresponding to the expected specifications, and therefore product safety.

GMP is a pillar of the new European Regulation for Cosmetics and has always been a mandatory requirement under the Directive, and remains so under the Regulation. The main difference is the reference to harmonised standard, EN ISO 22716:2007 and its presumption of conformity to the Regulation’s GMP requirements. It sets very high requirements to ensure consumers’ safety. Amongst these new legal requirements, 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.

What Do You Know About ISO 22716?

One way to demonstrate compliance with GMP is to implement international standard ISO 22716, an internationally recognised standard describing the Cosmetics Good Manufacturing Practices. The standard’s guidelines will provide a management system approach and practical methods to manage the many factors that can affect product quality. The scope of ISO 22716 is not limited to production activities, but also includes control, procedure documentation, storage and shipment. 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.

Key elements of ISO 22716 include, but are not limited to:

  • Quality organisation and responsibilities
  • Personnel and training
  • Internal audit (continuous improvement)
  • Supplier controls
  • Materials management
  • Cleaning and sanitisation

What Comprises a Cosmetic Product?

Articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance. Some examples include: bath products (shampoo, bath gel, etc.), body and skin care (skin cream, lotion, body scrub, etc.), colour cosmetics (lipstick, makeup powder, mascara, etc.), perfumes, fingernail polishes, toothpastes and deodorants.

Why Implement Cosmetics GMP ISO 22716 Now?

The world’s largest cosmetic manufacturers (51 in total) cover the majority of the global market, which is estimated to generate over USD336 Billion in annual sales. There are literally hundreds of other small to medium size cosmetic manufacturers around the world and most of these currently do not have certification to ISO 22716.

The immediate dilemma facing such organisations is the potential to lose their overseas markets unless they act quickly to comply with the new regulations, by attaining ISO 22716 certification.

ISO 22716 ensures the quality of production and the safety of cosmetic products throughout the supply chain, from raw materials to distribution. It can be implemented by organisations of any size, anywhere in the world.

With this certificate, an organisation can prove the compliance with the new requirements of ISO 22716 standard to their retailers, traders, buyers, business partners and other interested parties etc. as well as to facilitate legal inspections by health authorities. Some key benefits include:

  • Gain the confidence of the public, business partners and supervisory bodies.
  • Easily prove compliance with the new regulatory requirements in the field of cosmetics.
  • Increase your competitive advantage in the market.
  • Facilitate entry into the EU and global markets.
  • Continuous improvement and enhanced operating efficiency.

Don’t be alarmed, help is available

There is a great deal of work ahead for the cosmetics industry to ensure practices and procedures are aligned, cosmetic product information is readily available to the safety assessor, the product information file is updated, and so on.

SGS provides Compliance Audits, Gap Audits and Training for compliance to ISO 22716. In addition, we provide Laboratory Testing Services ranging from analytical chemistry, extractable and leachable testing, container testing, toxicological testing, eco-toxicology and biodegradability testing, safety testing (physical, chemical and microbiological), and the stability studies for formulation development.

As a trusted third party, we help you to effectively manage quality, safety and sustainability.