2011/65/EU (RoHS 2)

The RoHS 2 directive (2011/65/EU) is an evolution of the original directive and became law on 21 July 2011 and took effect 2 January 2013. It addresses the same substances as the original directive while improving regulatory conditions and legal clarity. It requires periodic reevaluations that facilitate gradual broadening of its requirements to cover additional electronic and electrical equipment, cables and spare parts. The CE logo now indicates compliance and RoHS 2 declaration of conformity is now detailed (see below).

In 2012, a final report from the European Commission revealed that some EU Member States considered all toys under the scope of the primary RoHS 1 Directive 2002/95/EC, irrespective of whether their primary or secondary functions were using electric currents or electromagnetic fields. From the implementation of RoHS 2 or RoHS Recast Directive 2011/65/EU on, all the concerned Member States will have to comply with the new regulation.

The key difference in the recast is that it is now necessary to demonstrate conformity in a similar way to the LVD and EMC directives. Not being able to show compliance in sufficiently detailed files, and not ensuring it is implemented in production is now a criminal offence. Like the other CE marking directives it mandates production control and traceability to the technical files. It describes 2 methods of achieving presumption of conformity (Directive 2011/65/EU Article 16.2), either technical files should include test data for all materials or a standard accepted in the official journal for the directive, is used. Currently the only standard is EN50581, a risk based method to reduce the amount of test data required (Harmonised Standards list for RoHS2 , OJEU C363/6).

One of the consequences of the requirement to demonstrate conformity is the requirement to know the exemption use of each component, otherwise it is not possible to know compliance when the product is placed on the market, the only point in time the product must be 'compliant'. Many do not understand that 'compliance' varies depending on what exemptions are in force and it is quite possible to make a non-compliant product with 'compliant' components. Compliance must be calculated on the day of placing on the market. In reality this means knowing the exemption status of all components and using up stock of old status parts before the expire date of the exemptions (Directive 2011/65/EU Article 7.b referring to Decision 768/2008/EC Module A Internal production control). Not having a system to manage this could be seen as a lack of diligence and a criminal prosecution could occur (UK Instrument 2012 N. 3032 section 39 Penalties).

RoHS2 also has a more dynamic approach to exemptions, creating an automatic expiration if exemptions are not renewed by requests from industry. Additionally new substances can be added to the controlled list, with 4 new substances expected to be controlled by 2019. All these mean greater information control and update systems are required.

Other differences include new responsibilities for importers and distributors and markings to improve traceability to the technical files. These are part of the NLF for directives and make the supply chain a more active part of the policing (Directive 2011/65/EU Articles 7, 9, 10).

(EU) 2015/863

Unlike the RoHS 2 directive (2011/65/EU), Directive 2015/863 adds four additional substances. Slated for adoption and publishing by EU governments internally by the end of 2016, the additional four substances shall be applied by 22 July 2019 except where exemptions permit as stated in Annex II. The four additional substances are

1.Bis(2-Ethylhexyl) phthalate (DEHP)

2.Benzyl butyl phthalate (BBP)

3.Dibutyl phthalate (DBP)

4.Diisobutyl phthalate (DIBP)

The maximum permitted concentrations in non-exempt products are 0.1%.

Restriction exemptions

There are over 80 exemptions, some of which are quite broad. Exemptions will automatically expire after 5 or 7 years unless renewed. 

According to Hewlett Packard: "The European Union is gradually narrowing the scope of and expiring many of the current RoHS exemptions. In addition, it is likely that new substance restrictions will be introduced in the next several years. 

Some exemptions: 

·Lead as an alloying element in steel containing up to 0.35% lead by weight, aluminum containing up to 0.4% lead by weight, and copper alloy containing up to 4% lead by weight is permitted. (Category 6c)

·Lead in high melting temperature type solders (i.e. lead based solder alloys containing 85% by weight or more lead). (Category 7a)

·"Lead in solders for servers, storage and storage array systems, network infrastructure equipment for switching, transmission, and network management for telecommunications." (Category 7b)

·Cadmium in Solar panels - Cadmium telluride (CdTe) thin-film PV modules in photovoltaic panels. The solar panel exemption was in the original 2003 RoHS regulation and it was further extended on May 27, 2011. 

·Limited amounts of mercury in fluorescent and other light bulbs where it is essential to their functioning comprise RoHS 2 Categories 1, 2, 3, and 4

Medical devices were exempt in the original directive RoHS 2 narrowed the exemption's scope to active implantable medical devices only (Category 4h). In Vitro Diagnostic Devices (IVDD) and other medical devices are now included.

Automotive vehicles are exempt (category 4f). Vehicles instead are addressed in the End of Life Vehicles Directive (Directive 2000/53/EC). 

Labeling and documentation

A RoHS mark

Products within scope of the RoHS2 directive must display the CE mark, the manufacturers name and address and a serial or batch number. Parties needing to know more detailed compliance information can find this on the EU Declaration of Conformity for the product as created by the manufacturer (Brand owner) responsible for the design or the EU representative. The regulation also requires most actors in the supply chain for the product (importer and distributors) to keep and check this document, as well as ensuring a conformance process has been followed and the correct language translation for instructions are provided. The manufacturer must keep certain documentation to demonstrate conformity, known as a technical file or technical records. The directive requires the manufacturer to demonstrate conformity by the use of test data for all materials or by following a harmonised standard (EN50581:2012 is the only standard at the time of writing). Regulators may request this file or, more likely, specific data from it as it will likely be very large.

History

RoHS did not require any specific product labeling, however many manufacturers have adopted their own compliance marks to reduce confusion. Visual indicators have included explicit "RoHS compliant" labels, green leaves, check marks, and "PB-Free" markings. Chinese RoHS labels, a lower case "e" within a circle with arrows, can also imply compliance.

The CE logo

The WEEE directive logo

RoHS 2 attempts to address this issue by requiring the aforementioned CE mark whose use is policed by the Trading Standards enforcement agency. It states that the only permitted indication of RoHS compliance is the CE mark. The closely related WEEE (Waste Electrical and Electronic Equipment Directive), which became law simultaneously with RoHS, depicts a trash-can logo with an "X" through it and often accompanies the CE mark.

CNAS Accreditation

FCC accreditation

Chemical test

Safety Test

Radiated Emission

SAR Test