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ATTENTION! Karty bezpečnostných údajov31 May 2018 is the final deadline for substances in range of 1 - 100 tonnes per year. Remaining time:
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RAC recommends an occupational exposure limit for benzene

At its March meeting, the Committee for Risk Assessment (RAC) also recommended occupational exposure limits (OELs) for two other substances: nickel and its compounds and acrylonitrile. These opinions conclude the response to the European Commission, which for the first time asked RAC to assess the scientific basis for setting OELs.

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Tobacco products - notification and reporting

NOTIFICATION OF TOBACCO PRODUCTS, ELECTRONIC CIGARETTES AND HERBAL PRODUCT FOR SMOKING

A. NOTIFICATION REQUIREMENTS FOR MANUFACTURERS AND IMPORTERS OF TOBACCO PRODUCTS TO THEIR COMPETENT AUTHORITIES
(CHAPTER 1, Article 5 of Directive 2014/40/EU):

  • a list of all ingredients, and quantities thereof, used in the manufacture of the tobacco products, in descending order of the weight of each ingredient included in the tobacco products;
  • information on emissions and their level;
  • internal and external studies and preferences of various consumer groups, including young people and current smokers, relating to ingredients and emissions, as well as executive summaries of any market surveys they carry out when launching new products.

A list of all ingredients includes:

  • the reasons for the inclusion of such ingredients in the tobacco products concerned.
  • toxicological data regarding the ingredients in burnt or unburnt form, as appropriate, referring in particular to their effects on the health of consumers and taking into account, inter alia, any addictive effects.
  • a statement setting out the reasons for the inclusion of such ingredients in the tobacco products concerned and status on registration.

Manufacturers and importers is required to specify, when submitting the information are consider to constitute trade secrets.

If the composition of a product is modified manufacturers or importers shall inform the competent authorities of the Member States concerned.

If a new tobacco product or tobacco product changed, submit the information required under Article 5 before such tobacco products.
Manufacturers and importers shall report their sales volumes per brand and type, reported in sticks or kilograms, and per Member State on a yearly basis starting from 1 January 2015.

For cigarettes and roll-your-own tobacco, a technical document setting out a general description of the additives used and their properties, shall be submitted by the manufacturer or importer. For tar, nicotine and carbon monoxide and for emissions, manufacturers and importers shall indicate the methods of measurement of emissions used.


B. NOTIFICATION REQUIREMENTS FOR MANUFACTURERS AND IMPORTERS OF LECTRONIC CIGARETTES
(CHAPTER III, Article 20 of Directive 2014/40/EU):

Manufacturers and importers of electronic cigarettes and refill containers shall submit a notification to the competent authorities of the Member States of any such products which they intend to place on the market.
The notification shall be submitted in electronic form six months before the intended placing on the market.
For electronic cigarettes and refill containers already placed on the market on 20 May 2016, the notification shall be submitted within six months of that date.
A new notification shall be submitted for each substantial modification of the product.

The notification includes:

a) the name and contact details of the manufacturer or importer into the Union,
b) a list of all ingredients contained in, and emissions resulting from the use of, the product, by brand name and type, including quantities thereof;
c) toxicological data regarding the product's ingredients and emissions, including when heated, referring in particular to their effects on the health of consumers when inhaled and taking into account, inter alia, any addictive effect;
d) information on the nicotine doses and uptake when consumed under normal or reasonably foreseeable conditions;
e) a description of the components of the product;
f) a declaration that the manufacturer and importer bear full responsibility for the quality and safety of the product, when placed on the market and used under normal or reasonably foreseeable conditions.

Manufacturer and importer are obliged to ensure that:

  • nicotine-containing liquid is only placed on the market in dedicated refill containers not exceeding a volume of 10 ml, in disposable electronic cigarettes or in single use cartridges and that the cartridges or tanks do not exceed a volume of 2 ml;
  • the nicotine-containing liquid does not contain nicotine in excess of 20 mg/ml;
  • the nicotine-containing liquid does not contain prohibit additives;
  • only ingredients of high purity are used in the manufacture of the nicotine-containing liquid. Substances other than the ingredients are only present in the nicotine-containing liquid in trace levels, if such traces are technically unavoidable during manufacture;
  • except for nicotine, only ingredients are used in the nicotine-containing liquid that do not pose a risk to human health in heated or unheated form;
  • electronic cigarettes deliver the nicotine doses at consistent levels under normal conditions of use;
  • electronic cigarettes and refill containers are child- and tamper-proof, are protected against breakage and leakage and have a mechanism that ensures refilling without leakage.

C. REPORTING OF INGREDIENTS OF HERBAL PRODUCTS FOR SMOKING
(CHAPTER III, Article 22 of Directive 2014/40/EU):

Manufacturers and importers of herbal products for smoking to submit to their competent authorities:

  • a list of all ingredients, and quantities thereof that are used in the manufacture of such products by brand name and type.


Manufacturers or importers shall also inform the competent authorities of the Member States concerned when the composition of a product is modified in a way that affects the information submitted.
The information required under this Article shall be submitted prior to the placing on the market of a new or modified herbal product for smoking.


HOW TO NOTIFY?

For tobacco products and related products placed on the market before 20. May 2016, manufactures and importers shall submit information under article 5, 20 and 22 to competent authority until 20. November 2016.

Notifications have to be submitted to MHRA through a European Common Entry Gate (EU-CEG) notification portal made available by the European Commission.

By registering in the EU-CEG system get your identification number ("ID number"), which shall indicate, for each sending of information about products through a system of EU-CEG.
NOTE: Sender ID number does not give you access to any other information or element of the EU-CE

  1. Create an account in authentication service of the European Commission (ECAS) and
  2. Complete and submit the form

NOTE: Complete the form as detailed as possible (including optional fields) and attach any official documents (eg. The registration certificate of the company or the confirmation of the implementation of Incorporation, the bill for public services, tax return).

After obtaining the ID number you have two options, both through EU-CEG send product information to EU Member States:

  1. Individual solution (for companies with small IT infrastructure):
    Companies use so-called generator to create XML files that can be EU-CEG upload later.
  2. Sending the system into the system (for companies with large IT infrastructure or quantity of products):
  3. To send the system into the system, you need access to the network electronic delivery (e-Delivery). This network operated by the Commission in order to enable the safe and reliable transmission of information. After obtaining your sender ID will contact the IT department of the Commission with further instructions on setting this technical solution.

More information available on web pages:
http://ec.europa.eu/health/euceg/step_by_step_en
Product type guidance (PDF, 168KB, 3 pages)
Submission type guidance (PDF, 412KB, 3 pages)
Emissions testing guidance (PDF, 93.9KB, 3 pages)
Nicotine dose guidance (PDF, 74.2KB, 2 pages)
UK ingredient guidance (PDF, 268KB, 3 pages)
Labelling guidance (PDF, 85.2KB, 2 pages)
UK product presentation guidance (PDF, 41.2KB, 4 pages)
E-cigarette and CLP Regulation guidance (PDF, 346KB, 3 pages)

REPEAL
(CHAPTER III, Article 31 of Directive 2014/40/EU):

Directive 2001/37/EC is repealed with effect from 20 May 2016, without prejudice to the obligations of the Member States relating to the time-limits for the transposition into national law of that Directive.

Member States may allow the following products, which are not in compliance with this Directive, to be placed on the market until 20 May 2017:

a) tobacco products manufactured or released for free circulation and labelled in accordance with Directive 2001/37/EC before 20 May 2016;
b) electronic cigarettes or refill containers manufactured or released for free circulation before 20 November 2016;
c) herbal products for smoking manufactured or released for free circulation before 20 May 2016.

 

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