Sunday 5 January 2014

Good Manufacturing Practices Cosmetic

ASECONSA can advise your company on the implementation of Good Manufacturing Practices Cosmetic and subsequent processing for obtaining the Certificate of Compliance.
Regulation (EC) 1223 /2009 of 30 November 2009 , the European Parliament and of the Council on cosmetic products in Article 8 establishes the obligation for the manufacture of cosmetics is carried out under the harmonized guidelines of Good Manufacturing Practice ( GMP) for cosmetics.
Currently these guidelines are contained in the UNE -EN ISO 22716 , " Cosmetics . Good manufacturing practice (GMP). Guide to good manufacturing practice . "
Among other competent authorities and bodies , the certificate of compliance with these guidelines may be issued by the Spanish Agency for Medicines and Health Products (AEMPS) upon application and payment of fees by the applicant in obtaining the certificate of Good Manufacturing Practices cosmetics.
As established by Regulation (EC) 1223 /2009, cosmetic products , those responsible for placing on the market of cosmetics in the European Union ( Responsible person ) shall ensure that all cosmetic products marketed under their responsibility have been made ​​as are harmonized guidelines including justification of compliance on file security information on Cosmetics ( cosmetic product Safety Report, CPSR) .
Therefore, to comply with the new European regulation on cosmetic products , manufacturers must certify their compliance with the UNE -EN ISO 22716 standard GMP .

Monday 20 December 2010

Communication of marketing of cosmetics

Responsible for the placing on the market of cosmetic products must send the relationship of products manufactured in Spain and/or imported into Spain, along with the places of manufacture and/or import them to the health authorities of the autonomous community where its head office, before the placing on the Community market is established.

This relationship must be submitted in duplicate and one of the copies shall be transferred to the Spanish Agency for medicines and health products for the corresponding autonomous community. Modifications affecting the data provided in connection with the existing legislation shall be communicated in the same way.

Such information may be submitted on the computer system of the AEMPS. In the event responsible for not has established its head office in Spain, is relationship will be sent to the Directorate-General of Pharmacy and health products of the Ministry of health, Social Affairs and equality.

Monday 18 October 2010

Cosmeceuticals and nutriceuticals: towards where we go?

The relationship between the food and cosmetic products with health is changing. The need to curb the signs of aging and prevent age-related problems are causing a change of trend in health care. Terms appear again as cosmeceuticals, nutriceuticals and nutricosmetic to group cosmetic and food products that by their biochemical functions on tissues help us to keep us healthy.
These new terms appear in the United States, Dr. Nicholas Perricone created her own line of products, baptized like cosmeceuticals and nutriceuticals, and agreed with the giant Johnson & Johnson marketing. From there, has created a lucrative healthcare Emporium some identified as fraudulent. The increase in the consumption of these products has soared in recent times.
Present these products as food and cosmetic accessories with active ingredients that trigger or favor biochemical reactions in the organism, reducing the aging and increasing the health of those who consume them. Without a doubt, resembles the definition of a medicinal product, which has raised more than a blister. Additionally, for its correct usage should be used as treatments, i.e. require marking guidelines and monitoring. Some medical associations of the US, the most active have been dermatologists, have requested that if these products are marketed with therapeutic properties, must be regarded as medicinal products and therefore demonstrate their therapeutic value and subject to a marketing authorization. They have led to the FDA published a communique in which dismissive of these products not to consider them medicines.
Products are already coming to Europe, where the normative regulation is much stricter than in us. The first question to answer is: what is a medication? (According to article 8.a) of law 29/2006 guarantees and rational use of medication and health products, medicinal product is any substance or combination of substances presented for treating or preventing disease in human that can be used or administered to human for the purpose of restoring, correcting or modifying physiological exerting a pharmacological, immunological or metabolic action functions, or making a medical diagnosis. Article 7(3) of the law 29/2006, sets that it will be a function of the Spanish Agency of medicines and health products (AEMPS) resolving on the attribution of the status of drug. And in case of doubt as to the possible attribution, is charged to the substance or combination of substances the aforementioned law (article 7.6), are therefore subject to all obligations to medicines.
It must also be taken into account are presented as food supplements (supplement the normal diet) and cosmetics (intended to be placed in contact with various surface parts of the human body in order to exclusive or primary clean them, perfuming them, change its appearance and/or correcting body odours and/or protecting them or keep them in good condition). If you have therapeutic properties or prevention and with a different purpose complete diet, clean, perfume, or modify the appearance, why are not medicines. Cause we find in the composition, recognized ingredients of these products cannot be considered active ingredients and their use is permitted in cosmetics and food supplements.
Then, the second question arises: what is the problem? The problem is that a substance may not occur or combination of substances in order to prevent or cure (medicine) without having to do so legally. The principle governing the labelling and advertising regulations is the defense of the consumer: no can mislead the consumer. According to the Royal Decree No. 1907/96 which regulates advertising and commercial promotion of products and services with so-called therapeutic purpose is clear in this regard, that all advertising or prohibited individualized mass direct or indirect promotion of products, substances, materials or methods that:
  • Seek therapeutic utility for one or more diseases without conform to the requirements and demands of law 29/2006 and its development rules.
  • Allocated to specific forms, presentations or brand of foodstuffs of regular consumption, concrete and specific preventive, therapeutic, or healing properties.
  • Allocated to food products (food supplements), destined for dietary or special regimes preventive properties, healing or other than such products in accordance with special regulations of the recognized.
  • Allocated to cosmetic products different to those products in accordance with special regulations of the recognized properties.
At this point, we can explain why some products with well known ingredients (vitamins, minerals, antioxidants, plants) are presented, advertised or promoted differently and give rise to the FDA has to publish an official statement on their website.
The first problem arises when these miracle, products with alleged properties that do not have been tested nor demonstrated are "identified or assimilate" like medicines within advertising or information to the consumer and not in the legal framework. The health authorities should ensure the safety of consumers and ensure compliance with the advertising rules of medicines and products for so-called therapeutic purpose. Too many cases of chronic patients who leave their medication by some innovative product have already been taken. Advertising for these products is covered in campaigns and Web sites and Word of mouth, which makes it very difficult or almost impossible its surveillance.
The second problem affects laboratories in cosmetics and food supplements. If these products are beginning to consider drugs, and were therefore subject to its legal obligations, the cost would be unbearable. Rumors suggest that are pharmaceutical laboratories which are behind this movement. Some already see in the new European regulation on cosmetics and restrictions of medicines from plants, which come into force in 2013, the early signs that laboratories want part of the cake of cosmetics and food supplements. We must remember the case of Depuralina, food supplement who withdrew from the market following the denunciation of a pharmaceutical laboratory.
Hopefully just increased vigilance of promotion and advertising of products and not have to go for the orange juice to the pharmacy for the bar to prevent colds.