Other Services

Autres services: batteries, packaging emballage, ISO 14001, prop 65, loi contre le traffic humain

ELV

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The End of Life Vehicles (ELV) regulation for automotive products is similar to RoHS.  Indeed, the same 4 heavy metals are restricted: cadmium, hexavalent chromium, lead and mercury.  Moreover, exemptions may apply and must be mentioned in the technical file, just like RoHS.  Because of these similarities, Enviropass follows the same conformity assessment approach for both RoHS and ELV.


Medical Devices

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According to the European Regulation 2017/745 on medical devices, the obligations listed in the following table will apply as of May 26th, 2020:

 

Topic

Extract

Reference

Design and manufacture

(…) Devices shall be designed and manufactured in such a way as to reduce as far as possible the risks posed by substances or particles, including wear debris, degradation products and processing residues, that may be released from the device. (…)

Annex I, article 10.4.1

Restrictions of substances

 

(…) Devices (…) shall only contain the following substances in a concentration that is above 0,1 % weight by weight (w/w) where justified (…):

(a) substances which are carcinogenic, mutagenic or toxic to reproduction (‘CMR’)  (…); or

(b) substances having endocrine-disrupting properties (…).

Annex I, article 10.4.1

Conditions for exemption

Justification regarding the presence of CMR and/or endocrine-disrupting substances (…) shall be based upon:

(a) an analysis and estimation of potential patient or user exposure to the substance;

(b) an analysis of possible alternative substances, materials or designs, including, where available, information about independent research, peer-reviewed studies, scientific opinions from relevant scientific committees and an analysis of the availability of such alternatives;

(c) argumentation as to why possible substance and/or material substitutes, if available, or design changes, if feasible, are inappropriate in relation to maintaining the functionality, performance and the benefit-risk ratios of the product;(…) and

(d) where applicable and available, the latest relevant scientific committee guidelines (…).

Annex I, article 10.4.2

Guidelines on phthalates

(…) the Commission shall (…) provide the relevant scientific committee with a mandate to prepare guidelines (...). The mandate for the committee shall encompass at least a benefit-risk assessment of the presence of phthalates which belong to either of the groups of substances referred to in points (a) and (b) of Section 10.4.1. The benefit-risk assessment shall take into account the intended purpose and context of the use of the device, as well as any available alternative substances and alternative materials, designs or medical treatments. When deemed appropriate on the basis of the latest scientific evidence, but at least every five years, the guidelines shall be updated.

Annex I, article 10.4.3

Guidelines on other CMR and endocrine-disrupting substances

(…) the Commission shall mandate the relevant scientific committee to prepare guidelines (…)

Annex I, article 10.4.4

Labelling

Where devices (…) contain substances referred to in points (a) or (b) of Section 10.4.1. in a concentration above 0,1 % weight by weight (w/w), the presence of those substances shall be labelled on the device itself and/or on the packaging for each unit or, where appropriate, on the sales packaging, with the list of such substances. (…)

Annex I, article 10.4.5

Latex

Substance to be declared to the Unique Device Identification (UDI) database

Annex VI, part B


Conflict Minerals

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Conflict minerals include tin (Sn), tantalum (Ta), tungsten (W) and gold (Au) (known as the 3TGs minerals) originating from areas of conflict such as the Democratic Republic of Congo (DRC) or its neighboring countries.

  • Since March 31 2014, a company listed on Wall Street must annually declare the origin of these minerals when used in its production and in accordance with the SEC (Securities and Exchange Commission)

 

  • If you are supplier of a US company governed by the rules of the SEC, then you will be asked for information on your 3TGs supply chain
  • No de minimis minimum threshold can exempt from the reporting obligation
  • The US federal law called Dodd-Frank Act, gives the rules on Conflict Minerals in section 150
  • This law massively affects manufacturers of electronic products, because they almost always contain at least one 3TG.
  • The European Union has prepared a similar bill as the United States’ one.

Batteries

  • Europe: Directives 2006/66/EC and 2013/56/EU on batteries and accumulators and waste batteries and accumulators
  • China: GB24427 Limitation of mercury,cadmium and lead contents for alkaline and non-alkaline zinc manganese dioxide batteries and GB24428 Limitation of mercury content for zinc silver oxide,zinc oxygen and zinc manganese dioxide button batteries
  • United States: NY Code - Section 27-0719: Battery management and disposal
  • Brazil: Batteries Conama Resolution No. 401
  • Turkey: Used batteries ans accumulators control regulation No. 25569
  • Switzerland: Verordnung vom 9. Juni 1986 über umweltgefährdende Stoffe (Stoffverordnung, StoV) No. 814.013
  • Taiwan: Order Huan-Shu-Fei-Tzu - Restriction on the Manufacture, Import, and the Sale of Dry Cell Batteries
  • Etc.

Around the world, laws regulate the concentrations of heavy metals (Pb, Me, Cd, Cr +6) in cells or batteries and impose binding limits, often stricter than the RoHS ones.

Enviropass helps you with the verification of these batteries within the electronic products you sell.


Packaging

Emballage Packaging

Packaged finished goods are also regulated due to the heavy concentration of metals they may contain.  Reknowned regulation laws in this category include: 


• In the United States - U.S. State Toxics in Packaging (TIP) (Section 95G of the Revised Code of Washington) and the USA Coalition of Northern Governments, known as CONEG

 
• In Europe – the packaging and packaging waste Directive 94/62/EC specifically requires the management of the declarations of conformity collected from packaging suppliers

Download
Template - declaration of conformity packaging / déclaration de conformité emballages
Packaging_certificate_of_compliance_Emba
Adobe Acrobat Document 221.3 KB

Enviropass performs compliance assessments for the packaging you use, whether it is in regard to labelling, technical documentation maintenance or simply following up with suppliers.


California's RoHS

Following the European RoHS 1 legislation of 2002, the State of California has enacted it own RoHS (Restriction of Hazardous Substances) regulation.  This regulation is similar to the EU RoHS version.

 

If you want to sell electronic or electrical products to California, Enviropass can provide you support to make sure you comply with these RoHS requirements.


Energy Efficiency

Energy Related Products (ErP)

The European Union Directive 2009/125/EC applies to energy related products (ErP) that ‘represent a significant volume of sales and trade’ (art. 15, paragraph 2(a)). Electrical and electronic devices, subassemblies and components are energy related products since they have ‘an impact on energy consumption during use’ (art. 2, definition 1).

 

The objective of this Directive, as well as its associated European Commission Regulations for enforcement, is to reduce the environmental impact of ErP. Enforcement actions include consumption efficiency targets, stand-by/off-mode functions and other eco-design specifications for certain product categories such as routers, interfaces, electric motors etc.

 

Importantly, these energy efficiency requirements are part of the CE marking obligations.

External Power Supplies

According to the International Efficiency Marking Protocol for External Power Supplies, which is the reference for the requirements in major markets, such as the European Union, the United StatesCanada or Australia.

 

Are the power supplies you use compliant with the energy efficiency standards and marking requirements ?


IEQC QC 080000

ISO 14001 système de gestion environnemental

IEQC QC 08000 is a system for the management of hazardous substances related to the RoHS and WEEE directives. Benefits are:

  • Showing due dilligence
  • Minimizing or eleminating the use of hazardous substances.

 QC 080000 is based on ISO 9000 quality management system. Enviropass can help you in the implementation of such a system.


Laws against Human Trafficking

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If you do business with a US Federal Government or if you own a place of business in California or in the UK, there is a good chance that you have to address human trafficking ban regulations. For example, the Californian law SB 657 targets tragedies of human trafficking and modern slavery in the present day workplace.

 

Enviropass supports you in searching for information and following up with your suppliers and subcontractors as well as advising you in the mandatory official disclosure on your supply chains control.


EcoDesign

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In a nutshell, EcoDesign is a solution to measure the environmental impacts of a new product.  It enables to monitor and to reduce energy and resources consumption of this product.  In addition, EcoDesign allows you to meet the ISO 14001-2015 Product Life Cycle (PLC) requirements of your environmental management system.

 

The EcoScans, or Eco-Design assessments, are part of the PLC exercise.  Several methods of EcoScans are available, such as the ReCiPe method.  In order to perform the Eco-Scans, it is necessary to have the following information of your new design:

  • Parts weights;
  • Materials specifications.

Any other questions on Eco-Design ?  You are welcome to ask Enviropass.