Any electronic or electrical device sold in the European Union must have a “RoHS Compliance Statement”. It does not matter what the origin of the material was. Any device, part, component, or material used in the assembly of the product requires documentation. For example, solders or raw materials used to manufacture plastics or materials used to manufacture metal chassis need to conform to the RoHS regulations.
Any motor, transformer, control panel, or other electrical product needs this document to be in compliance. In addition, It applies to any chemical substance used in these products.
The statement is officially known as a “Document of Conformity”. The actual regulations are presented later in this document.
What is RoHS?
RoHS is the “Restriction of Use of Hazardous Substances” regulations. They apply to any electrical or electronic device that contains any of the following substances:
1 – Lead
2 – Mercury
3 – Cadmium
4 – Hexavalent Chromium
5 – Polybrominated biphenyls (flame retardant)
6 – Polybrominated diphenyl ether (flame retardant)
7 – Bis (2-ethyl hexyl) phthalate
8 – Butyl benzylphthalate
9 – Dibutyl Phthalates
10 – Diisobutyl Phthalates
It also regulates any products and material that used any of these substances in their manufacture. More detail on RoHS are available in a separate article.
When is a Compliance Statement needed?
All electrical and electronic material manufactured in or exported to the European Union and any material used in the manufacture of electronic devices in the European Union need a compliance statement. It covers an extremely wide range of material. It is up to both the importer and manufacturer to assure that the RoHS documents are in order. Additionally, compliance letters should be kept up to 10 years by the importer or manufacturer.
Basically, a RoHS letter is needed anytime someone asks for one. A product either does or does not contain the chemicals covered by the regulations. Almost any material can be used for electrical and electronic components. However, it is illegal to make in or export to the European Union any material which does not have a compliance letter associated with it.
What can make a product non-compliant?
Using any wires or solders on any part of the product that contain over 1000 ppm lead cause non-compliance. Plastic housings may contain regulated flame retardants or plasticizers. Some anti-tilt or temperature sensing devices may contain mercury.
It is important to note that it does not actually depend on the amount of a out of compliance material that is used in a product. A microscopic amount of a lead solder used in a 1000-pound motor, makes it non-compliant. This is because the solder is considered an individual component and if it contains over 1000 ppm or 0.1% by weight lead or any other substance it is in violation. For example, a single zinc plated screw treated with a gold hexavalent chromium coating makes the product non-compliant.
What are the regulations that cover the documentation?
The required documentation is covered in the European Union Directive 201/65/EU which describes the RoHS regulations. There are several sections related to the required documentation including Article 13, 14, 15, and 16 and Annex VI.
Annex VI – Outline of the documentation.
This section has the meat of what a certification letter requires. This is Custom Designed Chemicals outline. There is no actual set form that needs to be filled out. But the letter must contain the following information.
1 – The unique name or identification of the product.
2 – The name and address of the manufacturer.
3 – the text “This declaration of conformity is issued under the sole responsibility of the manufacturer”.
4 – A description of what the material.
5 – The text: The object of the declaration described above (or the name of the product) “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.”
6 – Any references to testing or documentation used to determine conformity. The documentation does not have to be provided in the letter but it needs to be available.
7 – Signature, printed name, title, date, location.
It is a good idea and the usual procedure to put the letter on company letterhead. Although it does not appear it is a requirement. We recommend using letterhead.
When Custom Designed Chemicals prepares a conformity letter, we put it on letterhead and include the conformity symbol “CE”. This is available from the European Union website.
Article 13
This section states that a declaration of conformity is needed and describes where the requirements of conformity are located (Article 4). The document also has to be translated into the language of the member state where the product is marketed or imported to. Also. it says that the manufacturer is responsible for compliance.
Article 14 and 15
These relate to the use of the stylized “CE” logo that certifies a material conforms to the regulations. Only the manufacturer of the product can affix the logo. It is illegal to affix the logo to non-compliant materials. The logo indicates that the manufacturer attests to the compliance of the material. The size of the logo can vary but must be at least 5 millimeters high. The proper proportions must be maintained in the logo. It may not be lengthened or shortened except in proportion.
Article 16
This article states that affixing the “CE” logo in the absence of any other documentation certifies that the material is compliant. It also states that certain materials may be designated by the EU government as being certified if they are declared in subsequent laws.
Text of the Regulations
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
Annex VI
EU 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.
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):
Article 13 EU declaration of conformity
1 – The EU declaration of conformity shall state that it has been demonstrated that the requirements specified in Article 4 have been met.
2 – The EU declaration of conformity shall have the model structure and shall contain the elements specified in Annex VI and shall be updated. It shall be translated into the language or languages required by the Member State on the market of which the product is placed or made available. Where other applicable Union legislation requires the application of a conformity assessment procedure which is at least as stringent, compliance with the requirements of Article 4(1) of this Directive may be demonstrated within the context of that procedure. A single technical documentation may be drawn up.
3 – By drawing up the EU declaration of conformity, the manufacturer shall assume responsibility for the compliance of the EEE with this Directive.
Article 14 General principles of the CE marking
The CE marking shall be subject to the general principles set out in Article 30 of Regulation (EC) No 765/2008.
Article 15 Rules and conditions for affixing the CE marking
1- The CE marking shall be affixed visibly, legibly and indelibly to the finished EEE or to its data plate. Where that is not possible or not warranted on account of the nature of the EEE, it shall be affixed to the packaging and to the accompanying documents.
2 – The CE marking shall be affixed before the EEE is placed on the market.
3 – Member States shall build upon existing mechanisms to ensure the correct application of the regime governing the CE marking and take appropriate action in the event of improper use of the CE marking. Member States shall also provide for penalties for infringements, which may include criminal sanctions for serious infringements. Those penalties shall be proportionate to the seriousness of the offence and constitute an effective deterrent against improper use.
Article 16 Presumption of conformity
1 – In the absence of evidence to the contrary, Member States shall presume EEE bearing the CE marking to comply with this Directive.
2 – Materials, components and EEE on which tests and measurements demonstrating compliance with the requirements of Article 4 have been performed, or which have been assessed, in accordance with harmonised standards, the references of which have been published in the Official Journal of the European Union, shall be presumed to comply with the requirements of this Directive.
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