Trending Product Compliance Questions January 2018


Here is a sample of some questions product compliance people have been asking our Subject Matter Experts this month. You can find the full questions and answers below, but here is a summary of the topics covered:

  • EAEU RoHS deadlines
  • California’s Proposition 65 Clear and Reasonable Warnings label requirements
  • Non-compliance to WEEE in Germany
  • The amendment to “RoHS 2” Directive
  • Brazil’s proposed RoHS regulation

 

1) Question:  In relation to EAEU RoHS (Eurasian Economic Union Restriction of Hazardous Substances), what do we need to do before 2018/3/1? What do we need to do before 2020/3/1? Please explain the conditions that we do not need to do until 2020/3/1.

Answer: In theory, from 1 January 2018 electronic and electrical products in Annexes 2 and 3 may not be produced or sold in EAEU if their levels of lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls and polybrominated diphenyl ethers exceed the specified threshold limits.

However Decision No. 24, 2017 adopted by the Eurasian Commission on 24 February provided that a transition period will run from 1 March 2018 to 1 March 2020. During this period the electrical and radio electronic products (EEE) can be put on the EAEU market without mandatory confirmation of compliance with the EAEU TR 037/2016. So effectively manufacturers and suppliers of the products covered by EAEU RoHS may produce and place these products on the market without assessing conformity with RoHS technical requirements and without supplying any documents to evidence that conformity assessment has taken place.

From 1 March 2020 conformity assessment will be mandatory, along with the issuance of a declaration of conformity (which must also be registered) and the provision of product technical information.

 

2) Question: Concerning California’s Proposition 65 Clear and Reasonable Warnings label requirements: Is using the “short-form” warning on a product carton box acceptable or does it need to be on the product itself? If using this short form warning, do any other warnings need to be used at the (electronic) Point of Sale? Is there any enforcement against putting the short-form warning on products that may not require the label?

Answer: To comply with California’s Proposition 65 , the “short-form” warning may be used on the “immediate container or wrapper” as well as on the product. The amended language was intended to clarify that the short-form warning was sufficient in place of the longer formulation. In the regulation, the manufacturer’s obligation is to affix the warning to the product or label, and “label” means “a display of written, printed or graphic material that is printed on or affixed to a product or its immediate container or wrapper.”

No additional warning is required in addition to the short-form warning.

There is no prohibition against providing a warning where it is not required, so there is nothing wrong with putting the short-form warning on a product that may not require the label.

 

3) Question: What  are the sanctions for non-compliance to WEEE (Waste Electrical and Electronic Equipment) in Germany?

Answer: The German implementation of the European Union (EU) WEEE Directive is the Electrical and Electronic Equipment Act 2015 or “ElektroG”. Fines for non-compliance are set out in Section 45 of the ElektroG Act and vary from 10,000 to 100,000 Euro. For your ease of reference the text of Section 45 of the Act can be viewed by using the following URL: https://www.gesetze-im-internet.de/elektrog_2015/__45.html

 

4) Question:

The European Commission (EC) published the amendment to “RoHS 2” Directive on 21 November 2017, which is effective from 11/12/2017. Could you please help me understand if this amendment deletes the expiration date from the exemption 6b?

Answer: The EU Commission published 8 draft delegated directives to amend existing RoHS provisions, specifically regarding exemptions, on 19 September 2017. Amongst the exemptions covered and recommended for renewal by the Commission, for the period specified in the draft Annex, was 6(b).

The Commission favors the introduction of a new 6(b) as follows: 6(b) Lead as an alloying element in aluminium containing up to 0,4 % lead by weight

Expires on:

− 21 July 2021 for categories 8 and 9 other than in vitro diagnostic medical devices and industrial monitoring and control instruments;

− 21 July 2023 for category 8 in vitro diagnostic medical devices;

− 21 July 2024 for category 9 industrial monitoring and control instruments, and for category 11.

*6(b)-I *Lead as an alloying element in aluminium containing up to 0,4 % lead by weight, provided it stems from lead-bearing aluminium scrap recycling

Expires on 21 July 2021 for categories 1-7 and 10.

6(b)-II Lead as an alloying element in aluminium for machining purposes with a lead content up to 0,4 % by weight

Expires [three years after the publication of the Delegated Directive in the Official Journal] for categories 1-7 and 10.

The final Directive has not yet been published but we expect to be able to update you via C2P as soon as it is finalised.

 

5) Question: Is there any update on Brazil’s proposed RoHS regulation?

Answer: In a press release dated 26 December, Brazil’s Ministry of Environment (MMA) revealed that RoHS legislation is in the preparation phase, with entities manufacturing or importing electrical and electronic equipment  being called on to share their experience of EU RoHS via a questionnaire, to be submitted by 15 January at the latest.

The government is attempting to garner real market information to allow the drafting of a proposal appropriate to the Brazilian situation. Brazil does not currently have a specific RoHS standard in place, a legislative lacuna that is the source of concern for the Ministry in view of potential negative impacts on actors within the supply chain, the final consumer and ultimately the environment.

Existing measures relating to hazardous substances in consumer electronics include Normative Instruction No. 1/2010 which encourages public bodies to acquire products and materials that do not contain dangerous substances in concentrations above the EU RoHS recommended limits and ABNT IECQ Standard 080000:2010, a voluntary standard describing a management system for hazardous substances in electrical and electronic products and components.

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