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list In: Regulations person Posted By: Renzo Cattaneo

CLP, TPD and EU-ECG: let's talk briefly about compliance

The market is flooded with products that present significant problems in the labelling and technical-administrative documentation due, I propose two small comments I made recently on the subject in order to clarify the current situation with a focus on specialised retailers.

The market is flooded with products that present significant problems in the labelling and technical-administrative documentation due, I propose two small comments I made recently on the subject in order to clarify the current situation with a focus on specialised retailers.

There are TWO regulatory levels to comply with and the corresponding fulfilments:

1) clp regulation 1272/2008- ISS notification obligation and related labelling criteria, restrictions on the compositions of preparations limited, Italian language mandatory for both packaging and safety data sheets, no images, no names evoking foodstuffs.. In full force and effect with contents such as to render almost all American products etc. unmarketable...since ever...

2) TPD transposition via DL 6/2016 - further raising the normal/prescriptive bar implying compliant labels with even cigarette-like warning phrases. Sellable by manufacturers and distributors (it does not matter whether you are DF or DA it only matters that someone at the base has paid the tax if you are not DF) until 20 November 2016. Your possibility to finish the purchased stock (if not compliant also at this regulatory level, since the first one is in force and never had transitional entry into force and restriction) 20 May 2017, then destruction of the products. In level 2, there will also be qualitative conformity checks of products according to the criteria of dl 6/2016 and related registrations on the EU-ECG portal in any member state. Therefore, not all products will be eligible for registration also due to chemical composition problems, and products with regulated substances in excess of the limits will have to be discontinued unless their formulation is revised.

Lastly, all new products (i.e. those not notified to the ISS by 20 May 2016, in order to be sellable will have to have been registered for at least 6 months with the EU-ECG and not be, among other things, with nicotine concentration higher than 20 mg/ml and bottled in bottles with a capacity higher than 10ml. Nicotine-free products are exempt from the requirements of point 2 but not from those of point 1. In conclusion really, ALL products (with or without nicotine) MUST ALWAYS have specific safety data sheets in the language of the country in which they are marketed (this last requirement has been in force since 2008). I will save you REACH, but it is a loose cannon... we have already hit our heads with it.... Painfully!

"As for the disposal time of non-compliant products: it is not little indeed! According to the requirements of point 1 it is only 8 years that you cannot buy them (or rather you should not sell them), according to point 2 the time available is 1.5 years and the deadline before disposal is the notorious May 2017. Then if you pretend to stockpile for 10 years at the last day (20 November 2016) blatantly and further risking on your own the sale as traffickers I raise my hands....?? but let's also keep in mind that there is always the qualitative deterioration of the product expiry ... TMC.... Indicated on the label ??? ???? ) and not least the fashion...."

"With regard to names and images on products, the problem relates to substances classified as hazardous, Article 33 paragraph 2 of CLP Regulation 1272/2008  clarifies that the prohibition exists only for hazardous preparations as classified by the manufacturer. It should be noted that it is not the presence of nicotine that exclusively establishes the dangerousness of a preparation but rather the dangerousness resulting from the sum of all the components of the preparation itself: in principle, a preparation with nicotine could be non-dangerous and one without it could be due to the presence of other molecules that give it such classification characteristics".

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