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Obligation to register establishments and products, appoint a manager, adapt to good manufacturing practices, report serious adverse reactions suffered by consumers, keep records and safety tests: the rules for the export of cosmetics in the States are changing United States, the second market globally with 82.4 billion euros after Europe (88.3 billion euros) and the first outlet area for Italian beauty companies, with a share of 12.5% of the total for a value of over 730 million euro, up by 38.7%.
Il Mocra
The Food and Drug Administration (Fda) has in fact approved the “Mocra: Modernization of cosmetics regulation act”, a law that will enter into force starting from 2024 and which sets more restrictive rules to guarantee the safety of cosmetics by equating them to other regulated consumer products by the US government agency.
«It is necessary to start immediately to comply with the provisions of the new rules – recommends Lucio Miranda, president of ExportUSA, a consultancy company specialized in offering the services necessary to start up one’s business in the United States -. If Italian companies do not comply with the Mocra, the risk is that the goods will be blocked by the competent authorities”. Even importers will have to be registered with the FDA, which however “at the moment has not yet given access to the registration environment – continues Miranda -. If it were to emerge that, during registration, the importer must also enter the list of products to be imported, in fact the manufacturer would be forced to rely, first of all, on a registered importer and, subsequently, who has agreed to register the products to import. It is a situation which, from a commercial point of view, limits the sales activity by creating dependence on the importer. For companies that already export to the United States, if they have not yet done so, we recommend opening their own company under US law and registering it as an importer to ensure the necessary independence and operational flexibility on the American market».
The relapse
An important impact, therefore, on companies – around 1,500 Italian ones – both in terms of organization and a possible increase in operating costs to adapt to the new rules. «Certainly this new legislation goes in the right direction, with the aim of guaranteeing greater consumer protection and informing them in a more punctual and transparent way about the presence of allergens – comments Davide Bollati, president of the Davines Group. which realizes 30% of its turnover in the States, its main market –. In addition to setting up a dedicated portal for registration, the FDA will have to promulgate Good Manufacturing Practice regulations by next December, i.e. the production standards that companies will be required to comply with. To date, many points of the legislation have not yet been clarified, it is therefore difficult to predict their impact and consequent adjustment.
The year-end deadline for notifying products exported to the USA is very close, but the portal is not yet active and there is no information regarding its activation. We are talking about 800 products to be notified between our two brands Davines and Comfort Zone – continues Bollati -. Labeling requirements may lead us to revise most of ours as well. Added to this is the potential difficulty of having an “international” label. However, we are already well structured in compliance with high production and quality standards: however, there could be costs for any external consultancy or internal personnel to support the adaptation work or for the new labels and related codes».