Regulatory Timeline | Product Regulation – April 2016

Written on 14 Apr 2016

“This year is a significant one for the tobacco industry, with the Tobacco and Related Products Regulations 2016 and controversial Standardised Packaging of Tobacco Products Regulations both coming into force on 20 May 2016. In relation to the latter, the industry awaits the outcome of the litigation brought by four of the world’s heavyweight tobacco companies against the UK government.

There are also some updates on the automotive front, with a review of the current UK regulations underway and tighter rules for safer and cleaner cars being overhauled.”

Tom Harding, Associate Director, Osborne Clarke

22 March 2016 – Community Rolling Action Plan (CoRAP)

On 22 March 2016 the European Chemicals Agency (ECHA) adopted the final CoRAP for 2016-2018. CoRAP is a list of substances proposed by Member States for risk evaluation over a period of time. Substances are listed where there is a concern that they may pose a risk to human health or the environment. The ECHA encourages registrants of listed substances to coordinate their actions and to contact the evaluating Member State.

20 April 2016 – Consumer electrical product legislation

The following EU electrical product directives have been replaced with new versions:

  • Low Voltage Directive; 
  • Electromagnetic Compatibility Directive; and 
  • Radio Equipment & Telecommunications Terminal Equipment Directive (to be replaced with Radio Equipment Directive). 

All electrical products placed on the market in the UK/EU on or after 20 April 2016, caught by the new legislation, must comply with the new measures to avoid enforcement/sanctions. 

20 May 2016 – Tobacco and Related Products Regulations 2016 

The Tobacco and Related Products Regulations 2016, which will bring into effect the EU Tobacco Products Directive 2014, will come into force on 20 May 2016. The legislation governs the manufacturing, presentation and sale of tobacco products, but is not to be confused with the Standardised Packaging of Tobacco Products Regulations 2015 (see below). Amongst other things, the draft Regulations:

  • require the warning “Smoking kills – quit now” for tobacco products;
  • require the warning “This product contains nicotine which is a highly addictive substance” for e-ciggarettes; and 
  • introduce a registration scheme for cross-border distance sales of tobacco products, e-cigarettes and refills. 

20 May 2016 – Standardised Packaging of Tobacco Products Regulations

The controversial Standardised Packaging of Tobacco Products Regulations 2015 come into force on 20 May 2016. The Regulations are designed to make cigarettes less appealing to consumers and stipulate that cigarettes are only sold in packaging that is uniform in size, shape and design. Only the brand name (in non-distinctive typeface) and health-warnings can be printed on the box. Aside from the health warning, the packaging must be either dark brown or green in colour.

Four of the world’s largest tobacco firms have begun a legal challenge against the government, saying that it will infringe their intellectual property rights, and will not reduce smoking. The outcome of this challenge is pending.

20 July 2016 – New rules for infant and follow-on formula

The EU Regulation on Foods for Specific Groups, which comes into force on 20 July 2016, will set additional rules for manufacturers and sellers of infant and follow-on formula to comply with, by:

  • setting general compositional and labelling rules. This extends to the labelling of follow-on formula and the existing restriction of use of pictures or text which may idealize the use of products (currently only applicable to infant formula); and 
  • requiring the European Commission to replace the current Infant and Follow-on Formula Directive with new regulations.

2016 – Medical Devices Directive and In Vitro Diagnostic Medical Devices Directive

The European Commission has proposed to replace the current Medical Devices Directive and In Vitro Diagnostic Medical Devices Directive (implemented in the UK by the Medical Devices Regulations) with two new regulations, dealing with medical devices and in vitro diagnostic medical devices respectively.

The new legislation is still at draft stage and is being debated, but once in force will have direct effect and replace local UK legislation. We expect to know more in the coming months.

The focus is on ensuring patient safety via tighter restrictions on designation of notified bodies, increased transparency, traceability and market surveillance and greater protection of those undergoing clinical investigations.

1 July 2017 – Driverless cars

A full review and amendment of the current UK regulations is expected to be completed by summer 2017, with a view to accommodating driverless vehicle technology. The hope is that the legislative changes will mean that, at the very least, semi-autonomous vehicles are properly legislated for in the UK.

Thereafter, the UK government is predicting that this will link into a change in international regulations by 2018.

1 January 2018 – Novel Foods Regulation

The EU Novel Foods Regulation entered into force on 31 December 2015 and the majority of provisions will come into effect on 1 January 2018, though some are already in, or can be brought into effect before this date. It revises Regulation (EC) 258/97.

The Regulation aims to streamline the process for approval of novel foods for sale in the EU, and also to make the process cheaper, whilst ensuring food safety. It will also clarify the definition of novel food, which currently means foods and ingredients not consumed in the EU to a significant degree before 15 May 1997 (the date the current Novel Food Regulation entered into force).

TBC – Tighter rules for safer and “cleaner” cars

The European Commission is proposing to overhaul the current approval framework relating to the certification of vehicles and monitoring compliance with EU law.
The intention is to raise the quality and independence of vehicle testing, as well as to improve the oversight of cars already purchased. Under the current system, national authorities are responsible for checking the compliance of car manufacturers – these checks are currently paid for by car manufacturers, raising the possiblity of conflicts of interest. Amongst other changes, the new regime will modify this practice to avoid such financial links.
The new Regulation is currently in draft form and once adopted will repeal and replace the Framework Directive (2007/46/EC). The Commission is looking for the legislation to be finalised and adopted as soon as possible.

For more information and details of all of the other areas covered by the Regulatory Timeline click hereor download the full Timeline here.