EU Directive 2011/65/EU was published in 2011 by the EU, known as RoHS-Recast or RoHS 2. EU Directive 2011/65/EU includes a CE-marking requirement, with RoHS compliance now being required for CE marking of products. This was a major change that happened in 2011.

Originally it restricted 6 toxic substances;

• Cadmium (Cd): < 100 ppm
• Lead (Pb): < 1000 ppm
• Mercury (Hg): < 1000 ppm
• Hexavalent Chromium: (Cr VI) < 1000 ppm
• olybrominated Biphenyls (PBB): < 1000 ppm
• Polybrominated Diphenyl Ethers (PBDE): < 1000 ppm

There are a large number of exemptions detailed in Annex III of the EU Directive. Some products need the restricted substances to operate and therefore these products are listed with the allowable concentration of substance. The exceptions need to be updated on a regular basis, but can be withdrawn immediately !

In 2015 Annex II was updated with a Delegated Directive 2015/863, dated 31 March 2015, to include 4 more substances;

• Bis(2-Ethylhexyl) phthalate (DEHP): < 1000 ppm
• Benzyl butyl phthalate (BBP): < 1000 ppm
• Dibutyl phthalate (DBP): < 1000 ppm
• Diisobutyl phthalate (DIBP): < 1000 ppm

The restriction applied from 22 July 2019, with the restriction of DEHP, BBP, DBP and DIBP for some products being applied from 22 July 2021. Technical Documentation is mandatory for all applicable products.

Scope

1. This EU Directive shall, subject to paragraph 2, apply to EEE falling within the categories set out in Annex I.
2. Without prejudice to Article 4(3) and 4(4), Member States shall provide that EEE that was outside the scope of Directive 2002/95/EC, but which would not comply with this Directive, may nevertheless continue to be made available on the market until 22 July 2019.
3. This EU Directive shall apply without prejudice to the requirements of Union legislation on safety and health, and on chemicals, in particular Regulation (EC) No 1907/2006, as well as the requirements of specific Union waste management legislation.
4. This Directive does not apply to:
1. equipment which is necessary for the protection of the essential interests of the security of Member States, including arms, munitions and war material intended for specifically military purposes;
2. equipment designed to be sent into space;
3. equipment which is specifically designed, and is to be installed, as part of another type of equipment that is excluded or does not fall within the scope of this Directive, which can fulfil its function only if it is part of that equipment, and which can be replaced only by the same specifically designed equipment;
4. large-scale stationary industrial tools;
5. large-scale fixed installations;
6. means of transport for persons or goods, excluding electric two-wheel vehicles which are not type-approved;
7. non-road mobile machinery made available exclusively for professional use;
8. active implantable medical devices;
9. photovoltaic panels intended to be used in a system that is designed, assembled and installed by professionals for permanent use at a defined location to produce energy from solar light for public, commercial, industrial and residential applications;
10. equipment specifically designed solely for the purposes of research and development only made available on a business-to-business basis.

The Guidelines for this EU Directive gives a lot of direction with reference to the definitions of the exceptions. If your machine can be grouped into the exceptions (Has to be justified) it would remove the need to meet the requirements of the EU Directive.

Harmonised Standard

One Harmonized Standard is referenced by the RoHS EU Directive;

EN 63000:2018 Technical documentation for the assessment of electrical and electronic products with respect to the restriction of hazardous substances

EN 63000 specifies the technical documentation that the manufacturer compiles in order to declare compliance with the applicable substance restrictions.

The Harmonised Standard has to be conducted by the manufacturer, as part of the component buying process.

Declaration of Conformity

1. No … (unique identification of the EEE):
2. Name and address of the manufacturer or his authorised representative:
3. This declaration of conformity is issued under the sole responsibility of the manufacturer (or installer):
4. Object of the declaration (identification of EEE allowing traceability. It may include a photograph, where appropriate):
5. The object of the declaration described above is in conformity with Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment (1):
6. Where applicable, references to the relevant harmonised standards used or references to the technical specifications in relation to which conformity is declared:
7. Additional information:
   Signed for and on behalf of: …
   (place and date of issue):
   (name, function) (signature):

Warning!

It will be more challenging to stay updated with this EU Directive and the substance updates. The updates are notified as Regulations. The exception list is always likely to be updated, as the exceptions are constantly being modified.