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Austria's Vaping Amendment a Stern Reminder There's More to TPD than You Think

by Chris Ford April 28, 2016

Austria's Vaping Amendment a Stern Reminder There's More to TPD than You Think

Austria has jumped on board with EU/TPD this month, reminding manufacturers that a product notification involves much more than gathering test reports for each product then hitting the market running. Manufacturers need to be prepared for unknown review time, and countless questions from various Competent Authorities who all have a different opinion about vaping.

The federal health ministry of Austria presented a draft proposal to parliament this month to amend the 1988 Tobacco Act of Austria. E-cigarettes and e-liquids have been considered consumer products in Austria and have not been subject to the tobacco regulations.

The amendments will ban smoking and vaping in some public spaces, and e-cigarettes will be added to the tobacco regulations. Most of the requirements, including product notification, market data notification, notification of adverse effects, and product and packaging restrictions are directly transposed from the EU/TPD, but it will prohibit cross-border sales. The draft will become effective on May 20, 2016.

Austria will introduce its own licensing system, requiring manufacturers and importers to obtain a license from the Federal Ministry of Health before placing products on the Austrian market.

Manufacturers and importers must provide the following in electronic form:

  • Description and instruction of the relevant product.
  • Information on constituents and emissions.
  • Scientific studies concerning toxicity and addictiveness of the product.
  • Documents concerning market research on consumer preferences, including young people and current smokers.
  • Risk-benefit analysis of the product, expected impact on cessation of tobacco consumption and expected consumer perceptions.

The review period has not been specified, but the good news is that if the required documents have already been submitted to the competent authority through the product notification system, manufacturers and importers will not need to resubmit them to the Ministry when they apply for licenses. The Ministry will post the registration fees on its website.

This doesn’t seem to present a significant shift from the EU/TPD, and won’t impact manufacturers and importers to a great degree. However, the notification process varies by country, and only a very small fraction of the member countries have opted to use the European Commission’s notification portal system. This means that manufacturers will need to be aware of the individual requirements for submission of notifications and the formats that are expected to be submitted to each country.

The notification itself is far more complex and detailed than it appears in the directive, and mistakes are very costly. There is no required time frame in which a Competent Authority must complete the review of a notification. The required information stated in the EU/TPD is only the basis of the review, and each country can dictate how any element is to be formatted, the labs that are authorized for testing, and the documentation requirements to demonstrate that the appropriate systems are established.

Even a single question raised by a reviewer can delay a product release for months. Worse, if the Competent Authority is not satisfied that a manufacturer has demonstrated its products meets all of the requirements, it will reject the market application, and the manufacturer will forfeit the review fee (which is some cases is thousands of dollars). Without specifically requiring that manufacturers and importers establish documented procedures, the directive is very clear in its requirements on the manufacturers and importers to be able to demonstrate that the products sold in Europe are consistent and meet the product and labeling requirements consistently. By submitting a notification to a Competent Authority for market approval of e-liquid products, companies accept to take on certain obligations placed upon manufacturers who market e-liquid product in Europe. This commitment includes: 

  • Sell only safe products.
  • Provide customers with information which tells them about the risks posed by the e-liquids the company sells and the precautions they can take against those risks.
  • Adopt measures which allow the company to be informed of any risks a product might pose and, if necessary, withdraw products from sale, warn consumers or recall products which prove to be unsafe. Except where it is not reasonable to do so, these measures include;
    • Marking company name and address on the product or packaging,
    • Marking a product reference or batch number on the product or packaging,
    • Carrying out sample testing of products,
    • Investigating complaints, and
    • Telling any other businesses who purchased e-liquids to about the results of safety monitoring.
  • Tell the Competent Authority in writing about any of the company's e-liquid products sold in Europe which are known to pose a risk to consumers.

By now, manufacturers and importers who intend to sell products in Europe or are currently selling products are preparing available information and collating into Technical Files which become the basis of the product notifications in Europe. Prior to beginning this process, these manufacturers would have:

  • Outlined the steps of the manufacturing process and developed batch records to capture the required production-related traceability data.
  • Identified the equipment used in manufacturing, including the maintenance, calibration and process validation. Manufacturers should have maintained calibration records that are traceable to NIST.
  • Outlined a process and defined a system for capturing information about suspected adverse effects on human health of their products sold and distributed in Europe, and taking the appropriate corrective action.
  • Established a system to document, investigate, and correct nonconformances and suspected adverse effects related to their products.
  • Established a system for performing the appropriate risk assessment in order to assess whether a product to be notified to the Competent Authorities poses a serious risk to the health and safety of consumers and thus whether one of the RAPEX notification criteria is met. The obligation to inform the authorities about dangerous products is an important element for improved market surveillance as it enables the competent authorities to monitor whether companies have taken appropriate measures to address the risks posed by a product already placed on the market and to order or take additional measures if necessary for avoiding risks.
  • Prepared a risk profile for each product sold in Europe to establish the baseline for meeting RAPEX criteria.
  • Outlined the process for performing rapid recall from the European market as part of the corrective action system.
  • Outlined the process for notifying the authorities of suspected adverse effects on human health of their products.
  • Established a system for collecting and reporting annually the required sales and distribution data to the Competent Authorities

Manufacturers should not be conducting toxicology emissions testing, until standards become available, and the Competent Authorities publish guidance on the accepted or accredited laboratories from which they will accept data. In the meantime, manufacturers have plenty to do in establishing the backbone of their EU/TPD systems. Without these systems in place, product approval is unlikely, especially in countries that intend to conduct more rigorous product reviews, like the UK. 

When these above predicate activities are completed, the manufacturer will have the necessary systems in place to collect the required information, reports and data needed for the Technical File for each product, and will significantly improve the odds of product approval on the first round of review.

Chris Ford
Chris Ford


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