Category: Blog

Cosmetic products include a wide range of items (creams, shampoos, body care and hygiene products, but also make-up and sun care products), therefore, their use is extremely widespread and involves different types of consumers. However, not all stakeholders are aware of the legal obligations and rules that have to be respected in order to market a cosmetic in a manner that complies with industry regulations. The current reference text is Regulation (EC) No 1223/2009 of November 30th 2009, which is applicable from July 11th 2013; in addition, there are also other official documents and guidelines that help the different actors (manufacturers, cosmetic companies, distributors, etc.) in the sector to follow the legislation properly. For each cosmetic product, a responsible person...

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Obtaining the marketing authorisation for narcotics is a delicate procedure, regulated by specific norms whose compliance is carefully monitored by the Italian Ministry of Health. The authorisation to the wholesale of narcotics and psychotropic substances and all their preparations is issued by the central narcotics office of the Ministry of Health. It authorises those who obtain it to carry out business operations in Italy, in the European Union and in the rest of the world. Not every stakeholder of the pharmaceutical chain can, however, apply for this authorisation. For narcotics, the regulations in force provide for a very limited list of subjects that can apply for it and get it: warehouses and wholesalers of human and veterinary medicinal products having...

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In the summer, everyone needs to recharge their energy with a nice holiday, especially in this period, when the pandemic situation is taking its toll. Tourism can start again and so can the hotel industry. Many hotels, along with accommodation, also offer the possibility to access dedicated wellness centres. Offers combining business and pleasure includes proposals for the care and well-being of people. Big hotel facilities, including luxury hotels, can provide their clients with welcome courtesy lines and/or kits for beauty and hygiene. There are many examples of hotel cosmetics, that can also be customised on request. These are mainly bath products (soaps, shampoos…), that can be combined – especially in luxury hotels – with perfumes, beauty masks and/or body...

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What kind of responsibility has a European authorised representative of medical devices? The response is in the text of Regulation 2017/745 EU, applied as of 26 May 2021. Differently from what has happened for distributors and importers, the role of the authorised representative was already defined in Directive 93/42/EEC and in its national implementing text, Leg. Dec. 24 February 1997, no. 46. The level of responsibility of the authorised representative on legal issues caused or related to medical devices of extra-EU manufacturers according to the Directive was not particularly detailed. Actually, the only responsibility of the authorised representative was expressed in art. 18(a). At national level, on the other hand, Leg. Dec. 24 February 1997 – the Italian implementation of...

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N-nitrosamines are organic compounds that are possibly carcinogenic to humans. They are contained in some foods, in drink water supplies, and some classes of drugs. As of 2019, several EMA and AIFA guidelines have stressed that prolonged exposure above specific levels of N-nitrosamines increases the risk of cancer in humans, urgently requiring an accurate review of medicinal products to all MA holders of drugs containing chemical or biological active pharmaceutical ingredients (APIs), in order to prevent and contain N-nitrosamines content. The determination of the potential risk of N-nitrosamine formation/contamination is possible thanks to the support of the European Pharmacopoeia, that is continuously updated by EMA guidelines. The impurity control can be carried out consulting the monographs of the individual substances,...

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The agreement 0.946.526.81 on the mutual recognition of conformity assessment (MRA) has made easier, in the last 22 years, the free exchange of goods between the Swiss Confederation and the European Community. Such agreement also covers medical devices. For this category of products, on 26 May 2021 Regulation 2017/745 EU repealed Directive 93/42/EEC. The European Union and Switzerland have never reached an agreement allowing the update of the mutual recognition agreement within the new legislative framework. Basically, the European Commission subordinates the MRA update to the progress in the institutional agreements, whose negotiation is still going on. The European Commission is only available to negotiate the transitory provisions for medical devices according to the old legislation. Such circumstance implies, thus...

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Consumers’ food choices tend to vary in time and, especially in recent years, new types of foods have arrived on our tables. Possible causes can be identified in the growing ethnic variety and in an increased globalisation. This trend imposes, at regulatory level, the presence of a clear-cut, well-defined regulation allowing the marketing of food products that are safe for consumers. The concept of “novel food” is not a novelty at all. During history, in fact, new types of foods, ingredients or food manufacturing processes have appeared all over Europe from various regions of the world. The first European norm on novel foods goes back to Regulation (EC) 258/97 of the European Parliament and of the Council; however, the European...

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Food additives, flavours and enzymes are three categories of substances entering and playing a crucial role in the manufacturing chain of foods. The European Commission and EFSA continuously confront the industry need to develop manufacturing cycles that are more profitable thanks to the use of new food additives, flavours and enzymes. The development of new substances to be used in manufacturing aims to meet the food market trends: a market that is now extremely competitive and differentiated based on a growing consumer’s awareness. In this context, companies can create important opportunities, in accordance to the regulations’ prescriptions and incentives, to establish themselves in innovative, profitable and sustainable market areas. Enzymes Enzymes are proteins that can be isolated from plants, animals...

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The use of herbal ingredients in products intended for food consumption to favour some body functions and, more generally, to take care of our normal health state, is now a consolidated practice. Partly, the average consumer is still convinced that “natural” is a synonym of “healthy”; partly, research has investigated and confirmed some beneficial effects of plants, supported for a long time only by tradition. However, the use of substances deriving from plants in supplements has become so spread and rooted – and has generated a manufacturing industry of such magnitude – that it has drawn the attention of competent Authorities, then forced to regulate a sector that was at risk of wild development. Italy, it should be said, was...

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In a globalised world, harmonisation and standards are key elements allowing the acceptance and circulation of goods, systems, methods and applications. A standard is a shared modality enabling to do something in a repeatable way, yielding an outcome that is always the same. Internationally acknowledged standards in all fields allow more efficiency, absolute compliance with established requirements and a high level of quality. Standards can be of different nature: more often, they are criteria, methods, procedure guiding in the making of a product or service, fixed at international level by special committees, frequently referring to an international organisation. They are also continuously updated to keep pace with the progress of new technologies and with the specific needs of the market...

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