TPD: certifications do not exist

Among the many things one reads on the web referring to the TPD, the word certifications is among the most recurrent.

To summarise, however: certifications of inhalation liquids do not exist

Among the many things one reads on the web referring to the TPD, the word certifications is among the most recurrent.

To summarise, however: certifications of inhalation liquids do not exist

The term certification is abused for various reasons; let us first understand what a certification is in a general sense. Consulting the Treccani encyclopaedia one can read:

"The legal system does not define the notion of certification, but the Testo Unico della documentazione amministrativa (d.p.r. 28 dic. 2000 nr. 445) defines the 'certificate' (which, as mentioned above, is the document in which it is external), as the document 'issued by a public administration with the function of recognising, reproducing and sharing with third parties the states, personal qualities and facts contained in public registers, lists or records or in any other case"."

It follows that the first thing to check in order to know whether one can speak of certification is that there is a recognised certifying body. In the case of inhalation liquids to date, there are no such entities, which is not the case, for example, with tobacco products where DL 6/2016 clarifies in Article 4 paragraph 2 that "The measurement referred to in paragraph 1 is verified by the laboratory referred to in the decree of the Minister of Finance of 31 August 1994, published in the Official Gazette No. 232 of 4 October 1994, and by laboratories authorised pursuant to Article 5. These laboratories must not be owned or controlled directly or indirectly by the tobacco industry".

So if there is no certifying body, how can one speak of a certificate? A fortiori, how can one speak of self-certified?

Let's also try to understand how 'the certificate' is defined, i.e. the result of the certification activity. "In the context of accredited certification according to the standards of national and international standardisation bodies (UNI, ISO, etc.), certification is a very precise term, provided for by the UNI EN ISO 17000 standard. In synthetic terms, we can say that a certificate is an attestation of conformity (issued with respect to a specified specification, there is no such thing as generic certification) issued by a third and independent party, authorised (qualified, accredited, empowered) to do so (by law, by ISO standards and related recognition agreements, etc.)."

EAre there standards or specifications on the manufacture of inhalation liquids in Italy? Are there public or private authorised bodies? The answer is NO and therefore since none exist we are at the exclusion of the concept of certification/certification. Precisely because there is no specific legislation to be complied with that is irreferable to maximum values or test methods, the tests carried out to assess hot emissions can legitimately be defined as 'test reports' or 'analyses' without the technical/legal possibility of using the term certificate.

That being said, the procedure for entering an inhalation liquid into the European portal (Common Entry Gate) is carried out by providing a series of information regarding liquids that are NOTIFIED and not certified, the term used is SUBMISSION which literally means NOTIFICATION. Information must be provided on the hot emission of certain contaminants (but no upper limits), the CLP classification, the composition of the liquid, the amount of flavouring, the refill system, etc. This is all information that the manufacturer or importer provides under his own responsibility by declaring 'that the quality and safety of the product conforms to the standards when placed on the market and used under normal or reasonably foreseeable conditions'. Of course we are talking about the standards that exist such as the CLP regulation. This regulation, which has been in force since 2008, basically obliges 'producers' to warn with appropriate signs the warnings (H) or cautions (P) to be used for the consumption of a certain specific product once they have assessed its characteristics under their own responsibility. This assessment activity can be carried out by the manufacturer if he has the capacity to do so, or on his behalf by a professional, a body or company chosen by him if the prerequisites or technical necessity exist. It goes without saying that the responsible party is always and in any case the Manufacturer, since the Consultant performs an activity for this in the context of his inherent and consequent professional competence and responsibility.

Therefore, a product notified to the portal is not a product that has passed a 'state examination', but simply a product for which the characteristics, whatever they may be, have been declared under the responsibility of the manufacturer himself. Obviously, since the manufacturer or importer is the only entity recognised by law to carry out this activity in the event of, for example, problems in the use of the product, it is called upon to answer for them.

The consumer today, 'unfortunately' it has to be said, is not guaranteed the safety of the product but only warned of its characteristics. He is simply assured that the product he is consuming has been submitted to the European authority and all the information required to market it has been provided, nothing more. The usefulness of all this activity, however, is not an end in itself since the manufacturer is called upon to assume responsibility as mentioned above and this is certainly to the benefit of safety or at least to the condition of conscious use of the product by the consumer. Let us remember, however, that specifying the characteristics of the product and drawing up safety data sheets is nothing new, certainly the European legislation as transposed in Italy by dl 6/2016 certainly helps to reduce the jungle of the production of liquids without knowledge.

It is clear that in the event that the manufacturer is willing to take full responsibility and has specific skills to do so, he can carry out the activity of submission to the European portal in total autonomy and without a shadow of a doubt that he has arbitrarily and unlawfully assumed powers outside the scope of the current legislation, this because there are no regulatory constraints that can define a product's unmarketability on the basis of the actor who has declared its characteristics.

For those who would like to hear an authoritative opinion on the subject, I recommend the interview given by Dr. Ferri of FEM2, which can be consultedhere .