Natural Clinical Trials - EU Cosmetics Services

Natural Clinical Trials Network
www.NaturalClinicalTrials.net
European Union Cosmetics Article 7a Services
Natural Solutions Center
PO Box 96 Volcan, Panama.

Rima E. Laibow, MD - 973-241-4386
Robert Goodman, PhD - 718-547-4165
Ralph Fucetola JD - 973-300-4594

Article 7a Services Offered Through the Network

NEW ON THIS SITE: WEBINAR & SLIDE PRESENTATION


Link to Webinar: CLICK HERE.
Link to Slides: CLICK HERE.


Companies wishing to market cosmetics in the European Union are required to maintain certain records in the Product Information File (Dossier), in order to sell in the EU countries. Among the requirements is the Safety Assessment Certification provided by third party consultants, such as those of the Natural Clinical Trials Network.

Our Article 7a Services for Companies include:

1. Consultation regarding description of the qualitative and quantitative composition.
2. Confirmation of the physic-chemical and microbiological specification as certified by the responsible person at the Company; the Confirmation Document attests that our search of the scientific literature supports the specification as reported.
3. Consultation regarding description of the SOPs for method of manufacture complying with cGMPs.
4. Certified Assessment of Safety; this Certification Document shall take into consideration the general toxicological profile of the ingredients, their chemical structure and their level of exposure, and shall take particular account of the specific exposure characteristics of the areas on which the product will be applied or of the population for which it is intended.

The work product provided for the Company’s permanent records consists of four documents, with Dossier cover:

1. Letter of Opinion regarding the description of the qualitative and quantitative composition.
2. Attestation that our search of the scientific literature supports the physic-chemical and microbiological specification as reported.
3. Letter of Opinion regarding the Company’s SOP for cGMPs [SOP recommendations are a separate service offered by the Network].
4. Certified Assessment of Safety that the generally safe toxicological profile of the ingredients are supported by reliable and competent scientific evidence, when taking into account chemical structure and level of exposure.


The basic charge for the full Article 7a service package

1.The four letters, certifications & Dossier - $1,200.00 + $100 /ingredient > 3 ingredients
2.Standard Operating Procedures, from: $1,000.00

Required initial contact email: please email your initial contact to: "Robert Goodman" ,

Please copy and paste these questions into your email, with your answers:

1. Company name
2. Company address
3. Contact name
4. Contact email
5. Contact phone
6. Name of product(s)
7. General description of product(s)
8. Any "Look and Feel" claims currently being made in ads
9. Any "Look and Feel" claims currently on the label.
10. List of Ingredients and amounts or ratios (mark this "Proprietary") 11. Attach copy of label.

We will respond to your inquiry with our standard Article 7a Services Agreement for your number of ingredients. Upon signing the Agreement and paying the fee, we estimate a turn around time of ten business days for the average contract.

Thank you,

Dr. Laibow
Dr. Goodman
Counsel Fucetola
Excerpt from Article 7a

The manufacturer or his agent or the person to whose order a cosmetic product is manufactured or the person responsible for placing an imported cosmetic product on the Community market shall for control purposes keep the following information readily accessible to the competent authorities of the Member State concerned at the address specified on the label in accordance with Article 6 (1) (a):

(a) the qualitative and quantitative composition of the product; in the case of perfume compositions and perfumes, the name and code number of the composition and the identity of the supplier;
(b) the physico-chemical and microbiological specifications of the raw materials and the finished product and the purity and microbiological control criteria of the cosmetic product;
(c) the method of manufacture complying with the good manufacturing practice laid down by Community law or, failing that, laid down by the law of the Member State concerned; the person responsible for manufacture or first importation into the Community must possess an appropriate level of professional qualification or experience in accordance with the legislation and practice of the Member State which is the place of manufacture or first importation;
(d) assessment of the safety for human health of the finished product. To that end the manufacturer shall take into consideration the general toxicological profile of the ingredients, their chemical structure and their level of exposure. It shall take particular account of the specific exposure characteristics of the areas on which the product will be applied or of the population for which it is intended. There shall be inter alia a specific assessment for cosmetic products intended for use on children under the age of three and for cosmetic products intended exclusively for use in external intimate hygiene.


http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:1976L0768:20100301:en:PDF
© 2011 /v.08.08.11 -