European Union: RoHS: EU Phthalate Restrictions In Electrical And Electronic Equipment

RoHS refers to Directive 2011/65/EU on the restriction of the use of certain hazardous substances in electrical and electronic equipment (EEE). It is illegal to place EEE products on the market that are non-compliant with RoHS, and doing so risks criminal prosecution, with potentially unlimited fines on conviction.

The original RoHS legislation was made in 2003. Under RoHS, EEE must not contain the restricted substances, which comprised lead, cadmium, mercury, hexavalent chromium, polybrominated biphenyls (PBB) and polybrominated diphenyl ethers (PBDE). Only trace amounts, no higher than the specified "maximum concentration value by weight in homogeneous materials" may be tolerated. There are also exemptions for certain uses.

Now, Directive 2015/863, which updates RoHS, has added four phthalates (chemicals typically used to soften plastic) to the restricted list from 22 July 2019: butyl benzyl phthalate (BBP), di(2-ethylhexyl) phthalate (DEHP), dibutyl phthalate (DBP), and diisobutyl phthalate (DIBP).

The table below summarises the current restricted substances and maximum concentration values for these substances:

Medical devices

RoHS has applied to medical devices generally since 2014, and to in vitro diagnostic medical devices since 2016. RoHS does not currently apply to active implantable medical devices. For medical devices and monitoring and control instruments, the restrictions above will apply from 22 July 2021.

RoHS compliance

In order to comply with RoHS, manufacturers must:

• make sure that any EEE they place on the market has been designed and manufactured in accordance with the requirements set out in RoHS Article 4, which prohibits the inclusion of restricted substances;
• draw up the required technical documentation and carry out the internal production control procedure in line with module A of Annex II to Decision No 768/2008/EC or have it carried out;
• draw up an EU declaration of conformity and affix the CE marking on the finished product;
• keep the technical documentation and the EU declaration of conformity for 10 years after the EEE has been placed on the market;
• have procedures in place to ensure that series production remains in conformity; and
• keep a register of non-conforming EEE and product recalls and keep distributors informed thereof.

Labelling requirements

In addition, EEE must be labelled with:

• a type, batch or serial number;
• the manufacturer's name, registered trade name or registered trade mark;
• single contact address for the manufacturer; and
• where the size or nature of the EEE does not allow labelling on the product itself, the required information should be provided on the packaging or in a document accompanying the EEE.

This may overlap to some extent with labelling requirements under other legislation, which will also need to be observed, if applicable. For example, medical device legislation requires that the name and address of the manufacturer's authorised representative in the EU be included on the label.

The new Market Surveillance Regulation (EU) 2019/1020 also requires that certain product types include on the label details of an economic operator established in the EU. This does not apply to medical devices, and will not make a difference for some other products e.g. toys, where this was already a requirement, but it may affect other types of EEE that are subject to RoHS.

Brexit and RoHS

RoHS is implemented in the UK by the Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment Regulations 2012 SI 2012/3032. The responsible competent authority in the UK is the Office for Product Safety and Standards (OPSS).

The UK has indicated that it intends to continue regulating hazardous substances on the same basis after the UK leaves the EU: RoHS will be maintained in UK law through the Waste (Miscellaneous Amendments) (EU Exit) (No.2) Regulations 2019 (SI 2019/188), due to come into force on "exit day". The requirements will be substantially the same, save that the UK marking will replace CE marking with a UK equivalent mark. It has been suggested that products complying with EU requirements will continue to be placed on the UK market, at least for a period, but it is not clear whether products manufactured in accordance with UK requirements will be accepted as EU-compliant, unless they also comply with EU requirements.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.