Registrations & Approvals:

United States

FDA’s legal authority over cosmetics is unique, as cosmetic products and ingredients are not subject to FDA premarket approval, and cosmetic firms – not FDA – are responsible for substantiating the safety of a cosmetic product and its ingredients. However, cosmetics Cosmetics regulated under the Food, Drug and Cosmetic Actare regulated by the Federal Food, Drug and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act (FPLA), which prohibit the marketing of adulterated or misbranded cosmetics. If a cosmetic product is deemed misbranded or adulterated, or if a cosmetic firm fails to comply with safety regulations, then FDA may pursue enforcement action against products or firms that violate the law.

TSG offers numerous consulting services to the cosmetic and personal care products industry. Our consultants assist with a variety of product stewardship issues that may be encountered, including:


TSG and our European extension,


, have compiled all the information required for EU cosmetic product dossiers. Together, we have devised and commissioned safety and efficacy testing of cosmetics, toiletries, personal care products and household products destined for marketing and sale in the EU. Our cosmetics team is knowledgeable in all aspects of EU Regulation (EC) No 1223/2009, including:

▲ Qualitative and quantitative composition of the product

▲ The physico-chemical specifications of the raw materials and finished product

▲ Purity of the cosmetic product

▲ Method of manufacture

▲ Human health safety assessment of the finished product

▲ Proof of effect claimed for the cosmetic product.

The introduction of Regulation (EC) No 1223/2009, which came into effect on July 11, 2013, imposes more stringent procedures on organizations involved in the supply chain of cosmetics and personal care products.

To comply with these regulatory requirements, all cosmetic products being marketed within the European Union will have to be registered on the new Cosmetic Products Notification Portal (CPNP), which was set up in January 2012.

This regulation impacts the following types of businesses:
Lipstick cosmetics regulated in Europe under EU Cosmetic Regulation 1223/2009  
    contract manufacturers

TSGE can help identify the most direct route to achieve compliance with the new regulation, providing guidance and support on all regulatory requirements.

TSGE works closely with businesses to develop effective strategies and produce the necessary documentation and analysis to meet compliance requirements. TSGE’s key consultants in this sector have a long standing career in the cosmetics industry and are supported by a team of experienced scientists, including human health and cosmetic chemistry experts experienced in preparing product safety assessments and electronic notifications. These specialists can also advise on labeling and claims.

Some of the areas in which we support businesses include:

Cosmetic Product Safety Reports (CPSR): Our qualified safety assessors can ensure relevant and complete hazard and exposure data is gathered for cosmetic ingredients and products and provide safety assessment reports.

Product Information Files (PIFs): We help businesses prepare PIFs that are compliant and meet all regulatory requirements.

Responsible Person Support: TSGE provides assistance with local representation services for non-European manufacturers.

Safety Evaluation Without Animal Testing

TSG, in coordination with TSGE, provides general advice on the obligations and impact that the EU animal testing ban imposes on businesses. Our consultants determine how a company must proceed to comply with the EU Directive in order to market and sell their product in Europe. We also provide advice and strategies on how to address data deficiencies using QSARs, read-across, waivers, public domain data, data sharing and alternatives to animal tests.
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