Carl Mroz, Director - Regulatory Affairs
Are you faced with trying to keep up with changing regulations and different legislation around the globe? That is why Colorcon® – Your Formulation Partner™ has resources like Carl Mroz. As the Director of Regulatory Affairs, Mroz is closely involved with international regulatory activities that take place in the pharmaceutical and nutritional industries. For Colorcon, that means we are always current on changing regulations and legislative differences from a worldwide perspective. For our customers, that knowledge opens doors to opportunities for formulating with an understanding of what is acceptable around the world.
During our conversation with Mroz, we delve into those legislative differences and see how Colorcon’s involvement continues to make an impact on the industry - all to benefit our customers.
Q: How are coating materials and colors regulated under food and dietary supplements (nutritionals) in Europe?
A: In the European Union (EU), coating materials that form part of a food supplement product need to be either approved food additives or food ingredients.
Food additives are substances added to food intentionally for a technological purpose. The EU has a list of food additives formally approved in terms of safety. Some are restricted to the category of food that may be used and some have quantitative restrictions. For each approved food additive, the EU also has purity requirements in the form of a specification. Only substances that are approved and meet the relevant criteria of purity can be given an “E” number designation. For example, E 464 denotes hydroxypropyl methyl cellulose, which meets the purity requirements. Colors are considered to be one category of food additive. Some colors that may be added to food products, including food supplements, may be used without restriction and others have a maximum quantitative limit.
On the other hand, food ingredients are substances such as sugars and starches, which are consumed as part of the normal diet. Food ingredients used in this application must be safe for human consumption and meet the general requirements of Regulation (EC) 178/2002.
Q. What is the impact of regulation changes on the use of colorants in Europe?
A. Currently, the EU is in the middle of an overhaul of its legislation regarding food additives and flavors. This exercise is commonly known as the Food Improvement Agents Package (FIAP). Although this overhaul is intended to reformat existing legislation, without making substantial change, the opportunity is also being used to 'tweak' some specific areas. It is the FIAP process that introduced into European legislation the need for food products containing some specific colors to be labeled with a warning with respect to potential activity or attention issues in children.
Q: What are the main differences between the US vs. EU regulations?
A: One main difference in legislation relates to the list of substances that may be legally used in a dietary supplement in the US and the list of substances that may be used in food supplements in Europe. Although there is much overlap between the two lists, there are many substances that are allowed in the US, but not allowed in Europe and vice versa. One example of this is the respective lists of permitted colorants. Iron oxide is a widely used color for food supplements in Europe, but its use is not allowed currently in the US. In the US, it is possible to use materials in dietary supplements that fall into the classification of Generally Recognized As Safe (GRAS). However, such a classification scheme does not exist outside the US.
Q: Do other major geographies of the world have different regulations?
A: In some parts of the world, for example India and China, food supplement products are not legislated as foods, but as medicinal products. In these cases, the products must be licensed in the same way as drug products and their components selected according to pharmaceutical precedence of use.
Q. How has the Colorcon Regulatory Department helped the industry by introducing new materials for use in Europe and other jurisdictions?
A. Colorcon has always been very active in initiating change to national legislation, especially if there is a barrier to the use of best technologies. An excellent example of this is with polyvinyl alcohol (PVA) coatings of food supplement products. The use of PVA has great technological advantages in terms of moisture protection of coated tablets and reduces the need for expensive packaging. It also offers efficiency improvements in the actual coating process. Colorcon has petitioned internationally to add PVA to the list of permitted food additives, so it can be used in conjunction with food supplements. In the US, Colorcon coordinated various safety studies that concluded with PVA becoming GRAS for this application in 2004. In the EU, this project has now also been fruitful in that PVA will be allowed for this application by mid 2011.
Q. How does Colorcon help in formulating coatings that would be acceptable in the EU
and the US?
A. With years of experience in the area of formulating premixed products for coating solid oral dosage forms, Colorcon is ideally situated to match our product with both the substrate to be coated and the equipment that will be used. Having global interest, Colorcon participates actively in various trade organizations around the world so we are aware of upcoming changes. Our participation gives us the opportunity to comment on modifications and to ensure good science is being used to execute changes to legislation. In addition, Colorcon has developed internal databases to maintain the knowledge to work within any regulatory restrictions applied to specific components. For example, we continuously monitor regulations regarding acceptable colorants to ensure information is always current. The sum of all these factors place Colorcon in a perfect position to provide a customized solution to enable our customers to achieve their goals.
Carl Mroz and Colorcon’s entire global regulatory network are tightly integrated into all functions including, New Product Development, Technical Service, Production, Sales, and Marketing to ensure all Colorcon products meet the regional legislative standards for the markets where they are used.
For more information on US & Europe regulatory legislation, please view our on-demand nutritional webinars:
Carl Mroz, New Solutions for Coating Food Supplement Solid Dose Products - Meeting Changing European Regulations
Dave Schoneker, Navigating the Changing Regulatory and GMP Environment in the United States for Non-Dietary Ingredients
The award was presented Monday evening, May 24th, during the HSBC Brasil Ceremony with approximately two thousand people in attendance. This year marked Colorcon’s sixth time being recognized in this category, an achievement we hold in highest regard.
