Looking forward to further legislative developments in 2016 there are several things of note.
We now have confirmation that there will be four phthalates added to the RoHS list of restricted substances that become effective from July 2019 or July 2021 for product categories 8 (medical devices) and 9 (monitoring and control instruments). This takes the total number of RoHS2 (2011/65/EU) restricted substances to ten.
Several RoHS2 exemptions are set to expire on 22 July. Renewal requests for many existing exemptions are under review. If renewals are not granted the products that were “compliant by the use of an exemption” face becoming “non compliant”. Any Electrical and Electronic Equipment (EEE) that is already on the EU market on this date can continue to be sold. However, new EEE using expired exemptions cannot be placed on the market after the 22nd.
REACH has witnessed a change to the definition of complex articles. A preliminary ruling is in place at present and a final ruling, when it is announced, will be effective immediately.
Recently the European Court of Justice (ECJ) said the 0.1% threshold for notifying Substances of Very High Concern (SVHC) in articles applies to “each of the articles incorporated as a component of a complex product” rather than to the entire article as it has been previously interpreted.
This ruling could have a substantial impact on manufactures of finished electronic products where each individual component will need to have a REACH declaration before the complete product can be declared. Some manufactures may need hundreds of declarations from their suppliers before they can confirm their products do not contain a SVHC.
Five new SVHCs have been added to the REACH Candidate List for Authorisation taking the total to 168 substances. New additions include UV absorbers that may be found in plastics and a substance used in Li-ion battery electrolytes.
The Low Voltage and EMC Directives have been recast and take effect in April. There are no substantive changes in requirements but technical files should include “adequate analyses and assessments” of risk while manufacturer declarations of conformity should adhere to a new template.
The Radio and Telecommunications Terminal Equipment (R&TTE) Directive will be replaced by the Radio Equipment Directive (RED) in June.
The Directive ensures a single market for radio equipment by setting essential requirements for health and safety, electromagnetic compatibility and efficient use of the radio spectrum.
Finally, Conflict Mineral legislation is anticipated in Europe. Politicians are still shaping the legislation and it is unclear whether it will apply to downstream companies. A final decision is expected later in the year.