Quality Advisors

Belapur, Navi Mumbai, Maharashtra

ISO 22716

The objective of Gap Analysis audits is to evaluate the conformity of your facilities and processes with the Cosmetics Good Manufacturing Practices described by ISO 22716.The Gap Analysis will therefore help your organization to Continuous Improvement.

• Consumers’ safety

• Risk Assessment

• Cosmetics Product Quality

• Cosmetics Good Manufacturing Practices implement the new legal requirements described by the Cosmetics Product European Regulation.

FAQ

What are the new requirements for the New Cosmetics Regulation?

Every Cosmetic Product circulating onto the European Market will have to be produced according to the Good Manufacturing Practices. This applies to goods processed in the EU-27 countries as well as for all imported cosmetics.

Other requirements include an increased responsibility of producers and distributors, particularly regarding ingredients toxicity, product labeling, a more comprehensive product file and compulsory notification of new product introduction to the European Commission.

Other countries where the Cosmetics Market is well developed are also on the way to implement Good Manufacturing Practices as a compulsory requirement to enter their market.

The CE Mark is a conformity marking consisting of the letters CE. The CE Marking applies to products regulated by certain European health, safety and environmental protection legislation. The CE Marking is obligatory for products it applies to: the manufacturer affixes the marking in order to be allowed to sell his product in the European market.

CE is an abbreviation for Conformité Européenne, French for European Conformity. The CE Mark indicates that the product it is affixed to conforms to all relevant essential requirements and other applicable provisions that have been imposed upon it by means of European directives, and that the product has been subject to the appropriate conformity assessment procedure(s). The essential requirements refer, among other things, to safety, public health and consumer protection.

Please note:

• The CE Marking is not a quality-mark.
• First, it refers to safety rather than to the quality of a product. Second, CE Marking is mandatory for the product it applies to, whereas most quality markings are voluntary.
• Many people use the term CE Mark. Initially, this was the phrase used to indicate this conformity marking. However, CE Mark was officially replaced by the term CE Marking in 1993. Thus, it is better to speak of CE Marking.

The Benefits of implementing CE MARKING

• To be sold within the European market, certain products require CE-marking. The CE mark declares that your product complies with the Essential Requirements of the applicable EU Directives. Applicable requirements are set forth in various European Directives that replace individual country safety standards. The Directives apply to products manufactured within but also exported to the European Union.

• The CE marking is a kind of trade passport for the European marketplace: it allows the manufacturer to freely circulate their product throughout the 28 countries of the European Economic Area (EEA). There is only one set of requirements and procedures to comply with in designing and manufacturing a product for the entire EEA. The various and conflicting national regulations are eliminated. As a result, the product no longer needs to be adapted to the specific requirements of the different member states of the EEA.

In addition, it may be considered a benefit that by implementing the requirements, the product will be safer for the user and this may also reduce damage and liability claims.

Which type of product requires CE MARKING?

• Toys

• Machinery

• Electrical Equipment

• Electronic Equipment

• Personal protective equipment

• Pressure equipment

• Medical devices

• Active implantable medical devices

• In vitro diagnostic

• New hot water boilers

• Equipment and protective systems for use in explosive atmospheres

• Radio and Telecommunications terminal equipment

• Simple pressure vessels

• Gas appliances

• Lifts

• Recreational craft

• Non-automatic weighing instruments

• Cableways

• Construction products

• Explosives for civil use

• Measuring Equipment

What is the cost of CE MARKING

Cost will be calculated on the basis of the product and its application.