Regulatory Compliance
We help manufacturers, importers, distributors, and independent sellers to ensure that products that are placed on the market meet the requirements set out in relevant regulations.
We ensure that products and substances comply with the requirements of the regulation. Every product before being placed on the market must be in compliance with the regulations applicable in the specific area. Quality and compliance of the consumer products are usually different for every country and state. The obligation of the importer, distributor or manufacturer is to comply with all the legislations. Imported products are at particular risk of not being in compliance with the obligatory regulations. This is because of the different quality standards and required documentation in each specific area.
Depending on the type of product and region of the member state within EU27 there may be different internal regulations and requirements. Before marketing, the consumer product must be in compliance with the law that is specific to the member state. What does it mean? Product is in compliance when it meets all the regulations and requirements that apply to it.
Restricted and prohibited materials
It is very important to understand how different products categories are regulated. The first important point is chemical ingredients and materials regulations. A number of known and available chemicals and materials are prohibited or restricted. This differs from region to region. The responsible person must check if the product contains any prohibited ingredients, or impurities above the acceptable level, and if the product is safe.
Some of the chemicals which are not classified as dangerous in themselves may cause a risk in combination with others. That is why some of the materials require additional testing. Impurities derived from the raw materials must not be present above the allowed level. It is a common problem that imported consumer products like cosmetics, toys or household products contain a high level of heavy metals or other harmful substances. These products are not safe and should not marketed.
The person responsible for placing the products on the market
The European regulation EC No 1223/2009 defines the Responsible Person (RP) in article 4 as a legal or natural person based in the European Union who will act as the unique representative throughout the EU. The RP's role is to ensure that each cosmetic product or personal care product marketed in the EU countries complies with the requirements set out in the following annexes: Art. 3 Safety, Art. 8 Good Manufacturing Practices, Art. 10 Safety Assessment, Art. 11 Product documentation, Art. 12 Analyses, Art. 13 Notification, Art. 14 Compliance with Appendices, Art. 15 No CMR, Art. 16 Nanomaterials, Art. 17 Traces of prohibited substances, Art. 18 No tests on animals, Art. 19 Labelling, Art. 20 Declarations, Art. 21 Access to cosmetics, Art. 23 Internal control, Art. 24 Access to ingredients of the Cosmetics Regulation 1223/2009, which aims to establish that the cosmetic product is safe for use. The Responsible Person may be a manufacturer, importer, distributor, or any person established in the European Union. Usually, the one who places the product on the EU market will be the one who will ensure this role, unless a third person is designated.
Manufacturer
The Cosmetics Regulation defines the manufacturer as "any natural or legal person who manufactures a cosmetic product or has such a product designed or manufactured, and markets that cosmetic product under his name or trademark".
The manufacturer established within the EU is the Responsible Person for the cosmetic products it manufactures (in the EU) if they are not subject to being exported and reimported into the EU. The manufacturer may also designate any person established in the community by mandating someone with a written letter. The designated person must accept the role by responding in writing.
Importer
As defined by article 2 of the Cosmetics Regulation, an importer is "any natural or legal person established within the Community, who places a cosmetic product from a third country on the Community market."
Distributor
As defined by the EU Regulation No.1223/2009 a distributor is "any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a cosmetic product available on the community market."
The distributor is the Responsible Person if the product is placed on the market under his name or trademark or if he modifies a product already on the market and takes the risk of affecting the compliance to the Cosmetics Regulation. Any person established in the European Union can be the Responsible Person.
The manufacturer or the importer can designate a third party Responsible Person established in the EU to be a Responsible Person.
In this case the only formality required by the Cosmetics Regulation is a written agreement. The designated RP can be any legal or natural person who is able to endorse the responsibilities of the RP and comply with the regulatory requirements.