Consulting and expert reports for cosmetic products

Accordingly, all products must at least exhibit the following labelling elements:

• Name and address of the responsible person
• Use-by date or period after opening (PAO)
• Intended purpose of the product
• List of components (ingredient list) with identification of nanomaterials
• Batch identification
• Warnings or conditions of use, if applicable
• Specification of the filling quantity

We are highly familiar with the directives and regulations, will be happy to advise you on the labelling check and can prepare the necessary expert reports for your cosmetic products.

It must also be possible to check and adequately back-up efficacy claims made for cosmetics. We help cosmetic manufacturers to meet the requirements set down in Directive (EU) no. 655/2013 so that their products can be brought to market and sold to consumers.

Initial placement of cosmetic products onto the market

You want to launch a new cosmetic product onto the market for the first time and are unsure what exactly you have to do for this? Irrespective of whether notification and reporting obligations, the provision of documents or the performance of specific analytical tests are involved, the WESSLING experts will be delighted to help.

As safety assessors, we check the following, amongst others:

• The toxicological profile of the individual components
• The chemical structure or your product
• The type and extent of exposure

And use this to produce a comprehensive expert report that verifies the product's safety. Only an accordingly trained person is authorised to carry out such assessments.

The EU Cosmetics Directive set down clear and binding minimum requirements for the content of the safety assessment for the first time. Only a safety assessment that meets these minimum requirements guarantees that you bring your product into circulation properly.

Notification of cosmetic products

Notification is also mandatory in addition to the safety assessment of your product. This must be carried out electronically and includes information about the category of the cosmetic product, its country of origin and its composition, etc.

WESSLING undertakes both the notification of your products and initial registration in the European Union's CPNP portal (Cosmetic Products Notification Portal) for you.

Certain parts of cosmetic products are excepted from the REACh regulation. Diverse tasks nevertheless have to be performed along the value added chain, because the manufacturers are responsible for safe use of the chemicals.

WESSLING offers a team of experts to provide support in terms of the REACh regulation and chemicals law. This includes, for instance, assessing which role is assumed within the supply chain and which obligations arise from it. From legal requirements when importing or producing raw materials and the registration obligations that may arise from this to labelling in compliance with the chemicals law and the hazardous goods law requirements - our WESSLING experts are on hand to provide bespoke services for you and your product.

A total of 40 articles and ten annexes comprehensively regulate the safety and harmlessness to health of cosmetics. The regulation text is aimed at increasing the safety of cosmetic products whilst increasing the manufacturer's responsibility at the same time.

Amongst others, the legislation regulates the following points:

• Ban on the use of specific substances
• Substances with limited approval
• Regulations concerning dyes, preservatives and UV filters
• Labelling elements of cosmetic products
• Provision of certain product-specific documents (e.g. safety assessment)
• Manufacturer's notification and reporting obligations
• Specific regulations concerning the use of nanomaterials
• Verification of advertising claims
• Obligation of compliance with the principles of good manufacturing practice (GMP)

WESSLING's team of experts is familiar with the legal texts.

The German cosmetics regulations apply in addition to the EU Cosmetics Directive and regulate the following points:

• Linguistic requirements when labelling cosmetic products
• Notification obligations to the national authorities when bringing cosmetic products into circulation for the first time
• Regulations concerning criminal offences and administrative offences

Cosmetic products may only be sold to consumers subject to adherence to the given specifications.

Directive (EU) no. 655/2013 therefore defines criteria that have to be taken into account when using advertising claims for cosmetics. Protecting the consumer from misleading claims is the primary objective. As a result of this, common criteria for advertising claims were defined; these serve to inform consumers understandably and can be used to select a product.

All advertising claims in the form of texts, descriptions or images must meet these criteria:

1. Adherence to legal regulations
2. Truthfulness
3. Verifiability
4. Honesty
5. Integrity
6. Informed decision making

Do you have any questions regarding advertising claims as per EU Directive no. 655/2013? The WESSLING experts will support you in checking the corresponding specifications.

Amongst other aspects, the German finished packaging regulations specify the maximum negative deviation of the actual filling quantity from the filling quantity specified on the product. They also regulate whether the filling quantity has to be specified as a weight or volume as well as the font size required on the packaging. It must be noted that they only apply to products with a filling quantity between five grammes or millilitres and ten kilogrammes or litres.

Our finished packaging regulation services:

• Determination of the filling quantity of the cosmetic product
• Check of the font size for specifying the filling quantity on the product
• Check of the correct unit (millilitres or grammes)

In addition to this definition, the LFGB also regulates health protection and protection from fraudulent misrepresentation for cosmetic products. For instance, no misleading descriptions, information or images may be used. Bringing products that may be harmful to the health of consumers onto the market is also prohibited.

Compliance with the requirements of the LFGB is a mandatory prerequisite for being able to launch your cosmetic products onto the market safely.