Regulatory Affairs for Candurin®

Do you have any regulatory or safety questions concerning our food and pharma pigments? Our Regulatory Affairs managers are here to help.


Legacy of Quality

From the very beginning, the unrestricted promise of quality has been an essential element of our brand. As soon as 1851, Emanuel Merck guaranteed “the purity of my preparations” in a letter to his customers and pledged to “compensate for any damage that could arise from an impurity of my preparations.”

For many decades, we have been committed to the spirit of his signature - “the trust inspiring signature of the apothecary as a symbol for good quality and highest purity".

Our promise

We stand behind our pigments every step of the way from development up to delivery to you – our customers. The Regulatory Affairs managers are responsible for legal and safety issues relating to our technical pigments. In this capacity, they ensure that the statutory regulations are met. Their tasks also include substance registration in accordance with REACH (Registration, Evaluation and Authorization of Chemical Substances), ensuring the legal conformity of pigments in new application areas, raw material safety evaluations based on toxicological and ecotoxicological data as well as the environmental relevance of our pigments.

We work with national and international regulatory authorities, chemical industry associations (VCI, CEFIC) as well as scientific working groups. In addition, we are represented in the Association of Pigment Manufacturers/Mineral Colors and in the international working groups of the national pigment associations.

Furthermore, we support you when it comes to approval processes and general safety-relevant matters. We will inform you of the chemical inventory status of the pigment ingredients in the eight most important chemical inventories worldwide. 

Regulatory issues

Aflatoxins

Aflatoxins

Because you will need to be able to qualify raw materials for use in pharmaceutical and food products, you will need information on risk minimization of a potential contamination with aflatoxins.

For the food and pharma industries, we offer a wide range of raw materials for a variety of uses and provides Aflatoxin certificates. These products can be identified by their labels, such as pharmacopoeias, EMPROVE®, E-Number or FCC. In case of qualities for other applications, certificates can be issued on request if the intended use and the available specific information allow for it.

For the Aflatoxin certificates, we perform a risk assessment of the aflatoxin content. These certificates contain comprehensive data on the raw materials, information about the origin of a specific product and inform about a possible risk of mould or aflatoxins in the product.

However, as a supplier of raw materials, we do not carry out analysis of the aflatoxin content. Due to the nature of Aflatoxins and given the nature of storage or further production beyond its premises, it is not possible to guarantee the complete absence of aflatoxins.

Allergens

Allergens

We supply raw materials that could potentially contain allergenic substances. For the evaluation and declaration of these substances you will need 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, to be sure that we handover to you the right solution.

These products can be identified by their labels, such as pharmacopoeias, EMPROVE®, E-Number or FCC. In case of qualities for other applications, certificates can be issued on request if the intended use and the available specific information allow for it.

Our certificates cover a list of almost 40 substances known to cause adverse reactions in humans. The list contains all allergens, which require labeling by the European Food Labelling Directive 2000/13/EC, the US Food Allergen Labeling and Consumer Protection Act of 2004, and the Codex Alimentarius General Standard for the Labelling of Prepacked Foods (CODEX STAN 1-1985).

Comprehensive data on raw materials allow for the labeling of products according to legal requirements. Furthermore, this provides a reduced risk for allergy sufferers and enhanced consumer protection. 

BSE/TSE

BSE/TSE

Transmissible Spongiform Encephalopathies (TSE) include the bovine form occurring in cows (BSE), the scrapie-disease in sheep, as well as the human form, the variant-Creutzfeldt-Jakob-Disease (vCJD). Thus, we have taken all known measures outlined by the note for guidance EMEA/410/01 Rev. 02, classifying tissues by their potential risk of TSE infection.

FOOD’S PIGMENTS

To minimize the alimentary and iatrogenic contamination-risk, material with a potential risk of BSE/TSE-infectivity must be eliminated from the human and animal food-chain. Where animal derived material is concerned, careful attention is paid to its origin and inactivating treatment.

PHARMA’S PIGMENTS

To minimize the risk of exposure to BSE/TSE in laboratories, Merck KGaA, Darmstadt, Germany has developed granulated culture media. They minimize the formation of dust and reduce the spread of powder, thus reducing the risk of inhalation or lab contamination.Certificates can be ordered for a broad range of products, for production as well as for laboratory use. You would find information regarding the origin and, where applicable, the animal species, the type of tissue, the country of origin as well as the inactivating treatment.

GMO – Genetically Modified Organisms

GMO – Genetically Modified Organisms

In our certificates, you can find statements on the GMO status of our products in accordance with the most up-to-date European legislation. 

Genetic modification, an important tool to develop plant types with new resistant characteristics, has developed greatly in the past years, and legislation has developed accordingly. Since 2004, new legislation is in effect on labelling GMO in all EU countries. It makes the labelling of more products mandatory. Any known use of genetic modification appears on food labels so that consumers can use this information in their buying decision. Thus, as a manufacturer for end consumers, you need to know whether a specific product contains GMO or if material is produced from GMO. 

It is essential for you as manufacturer to build up and retain customer confidence. You need to show that you are responsive to consumer concerns. We even go beyond the legal requirements, making certificates available for products that are not yet on the EU’s list. And we can do this because we are up-to-date on the latest - and upcoming - developments in the field of regulatory affairs.

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 operate 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.Food additives in the sense of the Food Laws are substances that, by being used in food production, achieve certain technological effects and thus influence these foodstuffs in terms of their properties. As to whether any particular substance may be defined as a food additive, Merck KGaA, Darmstadt, Germany refers to the official regulations governing food additives.

Active pharmaceutical substances and additives are subject to GMP regulations as defined by 21 CFR parts 210 and 211 of the US Code of Federal Regulation and other European regulations and guidelines. Meanwhile, the current regulations for active substances and additives have been put into force (ICH Guide Q7 and Annex 2).

For more details, contact us

International Regulations

International Regulations

Our products must meet national and international laws for the respective intended purpose – worldwide. Due to our international organizational structure, we are able 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.In the pharmaceutical and food areas, different national standards are being replaced more and more by international, harmonized laws and regulations that play a role in the increasing globalization of the markets. 

It is a complex task to keep an overview of the constant changes and adjustments in standards - and this on an international basis. 

Our employees are represented in numerous national and international associations and working groups, in order to ensure observance and implementation of current legislation. This allows us to ensure that our raw materials and products meet ever-changing requirements. To support our customers, our standard policy is to give an overview of the registration status of our raw materials.

Halal

Halal

Halal means that food stuffs and pharmaceutical products and its components are “spiritually clean and permitted” under Islamic dietary law.

Certificates of an internationally recognized organization assure that the ingredients, production, handling and packing of these Merck KGaA, Darmstadt, Germany products comply with the Islamic religious requirements. Awareness and respect for the religious needs determine our processes and our responsibility.

Our customers for Food’s pigments can rely on a wide range of food additives that comply with Islamic law and are certified as being Halal.  

Our customers for Pharma’s pigments can rely on products certified accordingly to be strictly Halal despite the exceptions Islamic law allows for pharmaceuticals.

Kosher

Kosher

Kosher means that food stuffs and pharmaceutical products as well as its components are permitted under Jewish dietary law. The responsible rabbinical authority assures by means of a certificate that the ingredients, production, handling and packing of these Merck KGaA, Darmstadt, Germany products comply with religious requirements. 

Awareness and respect for the religious needs determine our processes and our responsibility.

Regarding our food’s pigments, customers can rely on a wide range of products for nutrition to be Kosher.  

Regarding our pharma’s pigments, customers can rely on a wide range of products for pharmaceutical use to be Kosher.

Membership in trade associations and working groups

Membership in trade associations and working groups

As a manufacturer, you are in close contact with the consumer. You know exactly how the market uses your products and you are the first to know when consumer requirements or laws change and when you have to carry out the necessary adjustments.

It is our priority to know the demands being placed on our products and the information you need. In order to keep pace with current developments in a fast-changing regulatory environment as well as the latest regulations, Merck KGaA, Darmstadt, Germany is a member of various industry associations, consortiums, working groups and committees. 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.

As a pharmaceutical and specialty chemical company, we have been committed to the high quality and safety of its products throughout its history since 1668. Combined to your in-depth knowledge of the market and our wide spectrum of knowledge, we complement each other perfectly.

For more details, contact us

Quality certification since 1851

Quality certification since 1851

Today, integrated quality management systems are the basis of our quality philosophy in all divisions of our company. 

Discover: TOPAS® – ensuring quality continuously 

Customer satisfaction as the basis of our company success roots in the high quality of products and services. The TOPAS® method (Transparent Optimized Process Analysis System) lines out the process landscape in various divisions and maps it out as a network.

  • TOPAS® links business processes with strategies and operational goals.  
  • TOPAS® allows for process costs analysis and shows the development of ROS and ROCE.  
  • TOPAS® supports risk analysis.As a process map TOPAS® depicts processes in a consequent and harmonized way, enabling staff and management to organize working processes in their daily routine in a more transparent, efficient and cost-effective way.

The results contribute considerably to the identification of improvement potential for the operational business. They strengthen the customer-supplier-relationship and are included in the certification process by the DQS.

The tradition of carefulness in all matters of quality is our customer guarantee. 

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