Scopo delle linee guida fornire una guida per l’applicazione del Regolamento (UE) n. 655/2013 della Commissione, sia argomentando ulteriormente i 6 principi di massima, sia fornendo alcuni esempi di comunicazioni non conformi e non ammesse in base ai sopracitati principi.
L’allegato I delle linee guida fornisce indicazioni su come interpretare i criteri comuni stabiliti dal regolamento (UE) n. 655/2013, fornendo esempi di dichiarazioni a carattere esemplificativo, ma non esaustivo. L’allegato II delle linee guida indica le Buone pratiche correlate al tipo di evidenze necessarie a supportare le dichiarazioni dei cosmetici.
E’ stato recentemente pubblicato sul portale della Commissione europea l’aggiornamento delle Linee guida della Commissione sull’applicazione del Regolamento 655/2013 sui criteri comuni. La pubblicazione, che sostituisce la precedente del 2013, aggiorna la stessa inserendo due nuovi allegati:
– III che riguarda le affermazioni “fre from” (senza)
– IV relativo all’uso del termine “ipoallergenico”.
Come per la precedente pubblicazione e comunque come per tutte le linee guida della Commissione, non si tratta di testi vincolanti dal punto di vista legale, ma solo di documenti di orientamento, poiché l’interpretazione autentica delle leggi è attribuita alla sola Corte di giustizia.
Sono documenti di orientamento che dovrebbero facilitare il compito degli operatori economici per meglio interpretare le norme e, nel caso specifico, per predisporre correttamente le pubblicità relative ai cosmetici ed il relativo controllo da parte delle Autorità preposte.
Come in precedenza comunque, nonostante si tratti del frutto di lavori lunghi e complessi che hanno impegnato esperti di varia estrazione e coinvolto vari Gruppi di lavoro della Commissione, i risultati ottenuti sono decisamente modesti, quanto tardivi, considerando soprattutto l’esponenziale crescita del “free from” nei cosmetici degli ultimi anni e la miriade di prodotti presenti sul mercato che riportano tali diciture abbinate ad una varietà infinita di ingredienti a vario titolo così “inesorabilmente” demonizzati.
Come detto le parti aggiunte sono riportate come allegati e rispettivamente III e IV:
l’allegato III riporta le line guida per ‘applicazione dei criteri comuni stabiliti dalla Commissione europea con il Regolamento (EU) No 655/2013 per quanto riguarda i claims “free from” e include una serie non esaustiva di claims “free from”;
l’allegato IV fornisce una guida all’applicazione dei criteri comuni stabiliti dal Regolamento della Commisssione (UE) No 655/2013per quanto riguarda lo specifico tipo di claim “ipoallergenico”.
Nel documento la Commissione precisa che, come stabilito nella riunione del 3 luglio 2017 con i rappresentanti degli Stati membri, la conformità dei prodotti a quanto contenuto negli allegati III e IV saranno oggetto di verifica da parte degli organismi preposti a partire dal 1 luglio 2019.
Il testo delle sopracitate linee guida nella versione disponibile in lingua inglese è reperibile sul portale della Commissione europea al link: https://ec.europa.eu/docsroom/documents/24847
Di seguito alcuni esempi:
“Free from” claims or claims with similar meaning should not be made concerning (an) ingredient(s) which is prohibited for use in cosmetics by Regulation (EC) No 1223/2009: The claim ‘free from Corticosteroids’ is not allowed, as Corticosteroids are banned by EU cosmetics legislation.
In case claims in relation to the absence of ingredients are made in relation to functional groups of ingredients that are defined in Regulation (EC) No 1223/2009, such as preservatives and colorants, the product should not contain any ingredient that belongs to the group as defined in this Regulation. If it is claimed on the product that it does not contain a specific ingredient(s), the ingredient should not be present or released: The claim ‘free from Formaldehyde’ is not allowed, if the product contains a formaldehyde releasing ingredient (e.g. Diazolidinyl Urea)
The absence of (a) specific ingredient(s) should be demonstrated by adequate and verifiable evidence:See Annex II on “Best practices applying to experimental studies”.
“Free from” claims or claims with similar meaning should not be allowed when they refer to an ingredient which is typically not used in the particular kind of cosmetic product: Fine fragrances usually contain such a high amount of alcohol that the additional use of preservatives is not necessary. In this case, it would be dishonest to highlight in advertising the fact that a certain fine fragrance does not contain any preservative.
“Free from” claims or claims with similar meaning should not be allowed when they imply guaranteed properties of the product, based on the absence of (an) ingredient(s), which cannot be given: The claim ‘free from allergenic/sensitizing substances’ is not allowed. A complete absence of the risk of an allergic reaction cannot be guaranteed and the product should not give the impression that it does
“Free from” claims or claims with similar meaning addressing functional groups of ingredients should not be allowed if the product contains ingredients with multiple functions and among these is the function that the product is claimed to be free from. Exceptions might be possible (e.g. based on challenge test results of the formula without the particular ingredient(s)): The claim ‘free from preservatives’ should not be used when a product contains (an) ingredient(s) showing a protective effect against microorganisms, which are not included in Annex V of Regulation 1223/2009, e. g. alcohol. If the responsible person has evidence that the particular ingredient or the combination of such ingredients does not contribute to the product protection, it might be appropriate to use the claim (e.g. challenge test results of the formula without the particular ingredient). The claim ‘free from perfume’ should not be used when a product contains an ingredient which exerts a perfuming function in the product, regardless of its other possible functions in the product.
Free from” claims or claims with similar meaning should not be allowed when they imply a denigrating message, notably when they are mainly based on a presumed negative perception on the safety of the ingredient (or group of ingredients): Certain parabens are safe when used in accordance to Regulation (EC) No 1223/2009. Considering the fact that all cosmetic products must be safe, the claim ‘free from parabens’ should not be accepted, because it is denigrating the entire group of parabens. Phenoxyethanol and triclosan are safe when used according to the Cosmetics Regulation. Hence the claim free from these substances should not be accepted because it is denigrating authorised substances.
“Free from” claims or claims with similar meaning should be permitted when they allow an informed choice to a specific target group or groups of end users: The following claims should be permitted if they also comply with the other common criteria: ‘free from alcohol’, e.g. in a mouthwash intended as a family product; ‘free from animal-derived ingredients’, e.g. in products intended for vegans; or ‘free from acetone’, e.g. in nail polish, for users wishing to avoid its particular smell.
The claim “hypoallergenic” can only be used in cases, where the cosmetic product has been designed to minimize its allergenic potential. The responsible person should have evidence to support the claim by verifying and confirming a very low allergenic potential of the product through scientifically robust and statistically reliable data (for example reviewing post- marketing surveillance data, etc.). This assessment should be updated continuously in light of new data.
If a cosmetic product claims to be hypoallergenic, the presence of known allergens or allergen precursors should be totally avoided, in particular of substances or mixtures:
- identified as sensitizers by the SCCS or former committees assessing the safety of cosmetic ingredients;
- identified as skin sensitizers by other official risk assessment committees;
- falling under the classification of skin sensitizers of category 1, sub-category 1A or sub-category 1B, on the basis of new criteria set by the CLP Regulation18;
- identified by the company on the basis of the assessment of consumer complaints;
- generally recognized as sensitizers in scientific literature; or
- for which relevant data on their sensitizing potential are
The use of the claim “hypoallergenic” does not guarantee a complete absence of risk of an allergic reaction and the product should not give the impression that it does.
Regarding the use of human data in risk assessment of skin sensitisation, including ethical aspects, reference should be made to the SCCS “Memorandum on use of Human Data in risk assessment of skin sensitisation”, SCCS/1567/15, 15 December 2015.
The companies should consider whether consumers, in the respective country, understand the claim “hypoallergenic”. If necessary, further information or clarification regarding its meaning should be made available.
