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Allergen certificates for the pharmaceutical, food and cosmetics industries

Food | Pharma | Cosmetics

Allergen

For the segments pharmaceuticals, food and cosmetics Merck supplies 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, Merck issues different types of allergen certificates.

Merck4Food (食品)

Risk assessment of allergen content
For the food industry, Merck offers a wide range of raw materials for a variety of uses and provides allergen 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 precise risk assessment of substances with respect to allergens, we collect relevant information from raw material suppliers and evaluate the potential danger of contamination with allergens.

Subject of analysis are the raw materials and the manufacturing processes deployed.

Merck 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).

On a voluntary basis, the list has been expanded by some allergens that do not require labeling.

These certificates inform about the likeliness that allergenic substances are contained within the product sold by Merck.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.

Merck4Pharma (医薬・中間体)

Allergen certificates for the pharmaceutical and food industries
Merck offers a wide range of raw materials for a variety of uses.These can be identified by their labels.
As a rule, Merck provides allergen certificates for raw materials supplied to the pharmaceutical and food industries.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 information allow for it.

For the precise risk assessment of substances with respect to allergens, we collect relevant information from raw material suppliers and evaluate the potential danger of contamination with allergens.

Subject of analysis are the raw materials and the manufacturing processes deployed.

Merck 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).

On a voluntary basis, the list has been expanded by some allergens that do not require labeling.

These certificates inform about the likeliness that allergenic substances are contained within the product sold by Merck.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.

Merck4Cosmetics (化粧品)

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.Both cosmetic manufacturers and end consumers obtain valuable information that allow for a careful production process or a careful selection of the products.

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© Merck KGaA, Darmstadt, Germany, 2012

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