Regulations and Standard Updates

Today, following a request from the European Commission, the Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) provided Guidelines on the benefit-risk assessment of the presence, in the medical devices specified in the mandate, of phthalates which have one or more of the following properties: carcinogenic, mutagenic, toxic to reproduction (CMR) or endocrine-disrupting (ED).

On their basis, the Commission is launching a public consultation where interested parties are invited to submit their comments on the scientific evidence online by 29 April 2019.

These Guidelines describe the methodology on how to perform a benefit-risk assessment (BRA) for the justification of the presence of CMR 1A or 1B and/or ED phthalates (CMR/ED phthalates) in medical devices and/or or parts or materials used therein at percentages above 0.1% by weight (w/w). They also consider the evaluation of possible alternatives for these phthalates used in medical devices. They are intended to be used by the relevant stakeholders e.g. manufacturers, notified bodies and regulatory bodies. The approach of these Guidelines may also be used for a BRA of other CMR/ED substances present in medical devices.​

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On February 2019, four Decisions are enacted and announced by Egyptian Ministry of Trade and Industry . Manufacturers and importers of certain products are granted a transitional period of 6 months or more to comply with approved mandatory standards on safety, energy efficiency etc.

Concerned products include:

• food products
• televisons and display screens,
• air conditioners,heat pumps without air ducts,
• vacuum cleaners,
• toys,
• instant water heaters
• gas cylinders
• childcare products,
• glass panel
• diapers
• etc

The four decisions will be published by the Ministry in near future.

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On February, France published a list of safety standards for Bicycles and Electric-assisted Bicycles.

And a transitional period is provided:

"Products conforming to standards whose references have been published in the Official Journal of the French Republic by the notice of 11 July 2015 may be placed on the market until 13 April 2019 and marketed while supplies last. However, electric-assisted cycles in accordance with NF EN 15194 + A1 (January 2012) can be marketed until April 13, 2020 and marketed while supplies last. "

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Draft amendment to the Transport Regulations published by Israel Ministry of Transport and Road Safety. This draft amendment lowers trade barriers and includes the following major changes:

• Amends regulation 282 (paragraph 9) and allows for the import of type N2 vehicles complying with Canadian legislation;
• Amends regulation 351a (paragraph 13) and allows for the import of vehicles complying with American Federal or Canadian standardization;
• Amends regulations 364f and 364h (paragraphs 15-16) and allows for diplomatic and consular vehicles to be exempt from vehicle safety systems requirements that are not obligatory in their country of origin.

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New Zealand Ministry of Transport is revising the 2002 Land Transport Rule: Light-vehicle Brakes. There is a compelling case for mandating Advanced Braking Systems (ABS) as soon as possible because of the safety benefit it brings to motorcyclists. This amendment will incorporate updated minimum standards for new motorcycles, and in particular will introduce a requirement for advanced brake systems for motorcycles meeting internationally recognised standards from Australia, Europe, Japan and the United States entering the fleet. New model new motorcycles will need to comply with one of the four international standards from November 2019. Existing and used motorcycles will need to comply with these standards from November 2021. The reason the rule is proposed to be implemented on these dates is to reduce the risk of New Zealand receiving less safe motorbikes, with Australia bringing in these requirements on the same dates. The revised Rule will require advanced braking systems (anti-lock brakes or a combined braking system) for motorcycles, depending on the powerband. It will continue existing minimum standards for existing models and used vehicles, until 1 November 2021.

The proposed new braking standards are applicable in Europe, the United States, Japan and Australia, are internationally recognised and accepted in the international motor manufacturing industry. We do not anticipate that this rule change will produce a significant barrier to trade. The proposed restrictions relate only to registrations of motorcycles for the use of public roads.

Non-compliant motorcycles will still be able to be used off-road. The approved vehicle standards for brakes are:

• (a) Council Directive of 26 July 1971 on the approximation of the laws of the Member States relating to the braking devices of certain categories of motor vehicles and of their trailers (71/320/EEC);
• (b) Council Directive of 5 April 1993 on the braking of two or three-wheel motor vehicles (93/14/EEC);
• (c) UN/ECE Regulation No. 13, Uniform provisions concerning the approval of vehicles of categories M, N and O with regard to braking (E/ECE324- E/ECE/TRANS/505/Rev.1/Add.12);
• (d) UN/ECE Regulation No. 13-H, Uniform provisions concerning the approval of passenger cars with regard to braking (E/ECE324- E/ECE/TRANS/505/Rev.2/Add.12H);
• (e) UN/ECE Regulation No. 78, Uniform provisions concerning the approval of vehicles of category L with regard to braking (E/ECE/324- E/ECE/TRANS/505/Rev.1/Add.77);
• (f) Federal Motor Vehicle Safety Standard No. 105, Hydraulic Brake Systems;
• (g) Federal Motor Vehicle Safety Standard No. 122, Motorcycle Brake Systems;
• (h) Federal Motor Vehicle Safety Standard No. 135, Passenger Car Brake Systems;
• (i) Australian Design Rule 31, Hydraulic Brake Systems for Passenger Cars;
• (j) Australian Design Rule 33, Brake Systems for Motorcycles and Mopeds;
• (k) Australian Design Rule 35, Commercial Vehicle Brake Systems;
• (l) Technical Standard for Passenger Motor Vehicle Braking Systems (Japan);
• (m) Technical Standard for Two Wheeled Vehicle Brake Systems (Japan).

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