Regulatory Support

Do you have any regulatory questions concerning our pigments and actives? Here is the regulatory support section for you.


Overview

Regulatory support for cosmetics! We assure the compliance of our products to national and international regulations with respect to the application fields of our products. We are dedicated to keeping you informed about current legal requirements, essential changes, and adjustments of all relevant laws and guidelines. To fulfill regulatory requirements, the expertise of our Institute of Toxicology supports us with respect to safety aspects while Quality Control and Quality Assurance secure that the products keep in line with purity requirements and that all processes are in compliance with e.g. GMP standards. We closely follow and observe all changes in international regulations like the EU Cosmetics Regulation, FDA, and China Regulations and help you navigate the complicated landscape where an ingredient can be considered a cosmetic in one country and an OTC drug or quasi drug in another.

Animal Testing

Animal Testing

Animal protection is one of our highest priorities.

Necessity of animal testing, if no other safe methods are available

REACH, the new Chemical Directive of the European Union, stipulates that possible health risks to people and environmental damage as a result of chemicals need to be detected at an early stage and prevented. 

In many cases, we have only been able to identify the properties of the material and possible exposure through animal testing. This is required for new substances within the framework of chemical law, for food additives or medications, but also for the release of a new material within the framework of the EU Cosmetics Directive. So far, there are still no adequate, officially recognized alternative methods for all tests on animals. Research is required here to find suitable alternative methods - in vitro and in silico - and to acquire international recognition.

In cosmetics, animal testing is generally rejected. Whereas animal testing has already been prohibited for years for cosmetic finished products, animal testing on cosmetic raw materials has now been prohibited in Europe since March 2009. 

Cosmetic Allergens

Cosmetic Allergens

For the segments pharmaceuticals, food and cosmetics we supply raw materials that could potentially contain allergenic substances. For the evaluation and declaration of these substances the manufacturer needs information on the raw materials used. These are subject to different legal regulations depending on the industry in question.

Therefore, we issue different types of allergen certificates.

Testing of products for cosmetic allergens

With the 7th Amendment of the Cosmetics Directive a list of 26 substances was published (2003/15/EC, listed in Annex III) whose presence in cosmetic products frequently causes allergies.

The presence of so-called „cosmetic allergens” must be checked and openly declared to the customers. 

It has to be specifically declared on the label of finished cosmetic products if their concentration exceeds 0.001% in the case of “leave-on” products or 0.01% in the case of “rinse-off” products.On the basis of analytical tests or the manufacturing process the “allergen status” is defined for every cosmetic active ingredient or pigment. 

GMP & HACCP

GMP & HACCP

As a manufacturer of pharmaceutical active substances and excipients, food additives and other food ingredients as well as active cosmetic substances, we operates according to recognized international quality standards and relevant regulations.

These have varying degrees of stringency, depending on the product groups involved, but all follow the same goal of ensuring that the user or consumer is provided with the optimal product quality and best possible safety.

With the ISO Norm 22716 “Cosmetic-GMP-Guidelines on Good Manufacturing Practices”, as of 15.11.07, an international standard for cosmetics GMP has been established.These guidelines provide guidance regarding GMP for cosmetic products and take into account the specific needs of this sector by including acceptance criteria for cosmetic raw materials.

In order to be prepared for this new ISO Norm, our company together with other companies has issued the “EFfCI GMP Guide for Cosmetic Ingredients”. Our portfolio dedicated to the cosmetic industry is in compliance with the requirements of the EFfCI GMP Guide and the ISO Norm 22716 for cosmetics.

Cosmetic Industry Associations

Cosmetic Industry Associations

Membership in trade associations and working groups

We are committed to continue to be an active member. It will contribute both its expertise and resources to a global quality system to assure patients’ safety and to meet the pharmaceutical industry’s needs and regulatory requirements.

Extensive know-how and direct contact with customers 

To keep an overview of current market trends, we are a member of various industry associations and consortiums – including VCI IPEC and Rx-360 – in the pharmaceutical and chemical industry. This allows us to keep abreast of the latest developments in laws and regulations in, for example, Europe, the United States and Japan. 

Membership in national and international trade associations

To be able to monitor the trends and currents in markets, our employees are members of various national and European trade associations – such as EFfCI, COLIPA, TEGEWA, IKW and VCI – in the cosmetic and chemical industry. Moreover, we are working closely with the US association CTFA, today Personal Care Products Council (PCPC), and keeps up-to-date in topic-specific working committees and working groups. 

Cosmetic Ingredient Dossiers

Cosmetic Ingredient Dossiers

We always deliver a complete product dossier which comprises the chemical substance as well as all information required for the intended use. We observe the rule that a material does not become a product until it is accompanied by a complete documentation.

Apart from chemical and physical parameters, the quality of a substance is defined by the information which is available about it. With the introduction of GHS and REACH, the information provided in documentation has been much improved.

We provide our customers in the pharmaceutical, food and cosmetics industry with comprehensive documentation. This rationalizes administrative processes and cuts costs.

The Cosmetic Ingredient Dossier (CID) is a comprehensive set of documentation on an ingredient which is to be used in cosmetics. The documentation contains all information available to the manufacturer for the safe use of the ingredient in cosmetics, in accordance with the requirements of the EU Cosmetics Directive. Our CIDs are always up-to-date, both with regard to legal requirements for the cosmetics industry and product modifications.

EU Cosmetics Directive

EU Cosmetics Directive

The EU Cosmetics Directive forms the legal basis for manufacturing cosmetics in the European Union. In Germany, it has been implemented by way of the German Cosmetics Regulation.

Product conformity with the EU Cosmetics Directive 

Products developed by our company especially for cosmetic formulations, conform to the EU Cosmetics Directive. The original directive was adopted in 1976; so far seven amendments exist and a number of adaptation directives. 

The directive lists prohibited and allowed substances (coloring agents, preservatives and UV filters) as well as substances which may only be used subject to specified restrictions and conditions. All substances not expressly listed in the directive can be used within the framework of general requirements for chemical raw materials in cosmetic formulations. The company which releases the cosmetic to the market will bear all responsibility for ensuring that it is safe.

INCI

INCI

INCI (International Nomenclature of Cosmetic Ingredients) is an international designation for the declaration of the ingredients on the packaging of cosmetics. The INCI names are allocated by the American Cosmetic Association 'Personal Care Products Council' (PCPC, formerly CTFA) and are used internationally. The INCI designations are mainly intended to give allergy sufferers the opportunity to check the ingredients of a product before buying it.

INCI ensures transparency in cosmetics 

The INCI name is a 'must' for the declaration of cosmetic finished products. The declaration of the ingredients in accordance with the INCI system has been a legal requirement in the European Union since 1993. 

The registration of the INCI name of a raw material is usually performed online by the manufacturer of the raw materials. The declaration of ingredients in cosmetics with the INCI name is in descending order - referring to the quantity. The actual content level of individual components is not specified here. We provide an INCI name for all its cosmetic raw materials.

International Regulations

International Regulations

Our products have to meet national and international laws for the respective intended purpose – worldwide. Due to our international organizational structure, we are in a position to integrate and implement changes at an early stage in the legislative project.

This is ensured thanks to the close cooperation of our employees with national and international authorities, chemical associations (VCI, CEFIC) and cooperation in scientific working groups.

International Regulations 

Alongside the European Cosmetics Directive, there are further legal requirements in the cosmetics industry, e.g. in the US and Japan. Many countries orient their activities to these markets. Furthermore, there are countries that have enacted their own laws such as Australia, Canada, Korea – to name just a few. Some of the raw materials are very similarly regulated in these laws, whereas other completely different requirements have to be fulfilled, such as in the UV filter area.

Being aware of and observing international regulations is one of our company's strongest qualities. To maintain an overview of the constant changes and adjustments in legal regulations, our employees are represented in numerous national and international associations and working groups. To support our customers, it is our standard policy to give an overview of the registration status of our raw materials in Europe, the US and Japan. 

If it is available, information on the legal status of our products will be provided if desired.

Product Safety

Product Safety

To assure the safety of a raw material used for cosmetic applications, a series of toxicological tests are required. They form the basis for a safety evaluation. These tests can either be carried out on animals (in vivo) or on isolated cells (in vitro = alternative method). Regarding this, the EU has published “Notes of Guidance for the Testing of Cosmetic Ingredients and their Safety Evaluation”.

In the case of cosmetics, it is particularly important to obtain information concerning a possible sensitizing or irritating effect of a substance. Absorbing substances must be tested for phototoxic effects upon exposure to sunlight. In addition, it has to be known e.g. whether a raw material is suspected of causing cancer (carcinogenic=C), causing genetic mutations (mutagenic=M) or damaging reproduction (reprotoxic=R). Such substances are classified as CMR substances and are banned from use in cosmetic products.

We select which tests are to be carried out on a raw material depending on the application. The safety of the raw material is proven by toxicological studies and literature data. A human patch test is performed to obtain final information on the tolerability of the substance.

ECOCERT Certification

ECOCERT Certification

Our goal has always been to create products that are safe, reliable and effective. And now, we're proud to add "environmentally sound" to that list: several of our cosmetic ingredients have recently gained certification status from ECOCERT, the independent organization that represents the highest international standards for nature-friendly products. 

ECOCERT and us: At the forefront of the natural revolution

t’s extremely strict standards encompass the entire production chain: confirming that the raw materials can be traced back to environmentally responsible sources, ensuring that those materials stay pure through the manufacturing process and checking the manufacturing process itself for the lowest possible environmental impact. By requiring products to contain a high proportion of natural ingredients and stipulating that 95% of its ingredients are cultivated using organic methods, ECOCERT offers a truly comprehensive overview. We have demonstrated that we are up to the challenge. 

Harnessing the power of nature 

So why are more and more of our cosmetic ingredients receiving nature-friendly certification? It's because we believe that real efficacy comes from nature itself.

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