ROHS COMPLIANCE: THE PROCEDURE

Why an EU RoHS Procedure?

Legislation and standards restrict more and more hazardous substances found in electrical and electronic equipment (EEE). The most prominent regulation is certainly the EU RoHS – Restriction of the use of certain Hazardous Substances.

Those restrictions apply either to products or to production activities. They may involve product labeling such as the CE marking per EU RoHS, as well as different product assessments, subscriptions to agencies, specific statements, or declarations of conformity (DoC).

When exporting or placing finished goods into a specific market, the manufacturers must demonstrate that their in-scope products meet the applicable local substance restrictions. Precisely on EU RoHS, the article 7 paragraph (b) of the Directive 2011/65/EU of the European Parliament and of the Council requires manufacturers to:

”draw up the required technical documentation and carry out the internal production control procedure (…) or have it carried out.”

The goal of a procedure is to describe the environmental compliance management system of products, to show due diligence, and to declare compliance against applicable product environmental laws, like Eu RoHS. Any manufacturer introducing EEE in Europe should draft such a procedure, regardless of the ‘made in’ and country of origin.

What an EU RoHS Compliance Procedure should Contain

As a company, you should carry out risk analyses and determine the essential requirements applicable to your EEE products, such as RoHS, REACH SVHC, WEEE, California Proposition 65, and others. Your product technical documentation should record and include such risk analysis. It must be continuously updated over time and periodically revisited. Here are five steps that an EU RoHS procedure should encompass.

1. Explain how you Monitor your Product Environmental Requirements

Before assessing a product, the first step is to find out what the rules are. Consequently, the manufacturer must find the most recent versions of environment-related regulations worldwide and standards that apply to the EEE manufacturing industry. As you can imagine, these regulations evolve and you need to keep abreast of product environmental compliance.

Different resources are available, such as the Enviropass’ LinkedIn page and Environmental Compliance Newsletter, specialized associations (e.g. IPC), inter-governmental bodies (e.g. IEC), supranational bodies (e.g. European Union ECHA), national, federal (e.g. EPA). You can also take a course, like the three modules online Introduction to Product Environmental Compliance.

Once you know what the potentially applicable product environmental requirements are, then it is recommended to apply a regulatory risk assessment and prioritize the standards and regulations of interest. There are many ways of performing such an assessment. For example, you can determine what is riskier in terms of product characteristics, markets, consumers, legal obligations, share-holders, etc. Your procedure should reveal your corporate choices and a specific internal form should be drafted and reflect what requirements are low medium and high risk.

As you can imagine, ”high risk” requirements will have to be prioritized. A summary should explain what is at stake in detail, if necessary, article per article, for every type of your in-scope EEE. The EU RoHS requirements are usually considered as high risk if we compare them to voluntary standards. Various countries, with national deviations, have also enacted RoHS-like regulations, such as China RoHS, Taiwan RoHS, the United Arab Emirates UAE RoHS, Russia RoHS, etc.

2. Set a RoHS Compliance Action Plan

According to EU RoHS, the manufacturer must conduct the applicable conformity assessments of its products or have them carried out. But in any case, the manufacturer is responsible for the conformity of its products.

Enviropass is here to help you assess your products against RoHS, REACH SVHC and Annex XVII, California Prop. 65, Persistent Organic Pollutants POP, and any other product environmental compliance requirements.

We highly recommend the documentary approach according to the IEC 63000 standard to perform the RoHS assessment of a complex product. This standard, for ‘technical documentation for the assessment of electrical and electronic products with respect to the restriction of hazardous substances‘ is well recognized by both the industry and enforcement authorities. It will help you save costs while giving reliable reports. Indeed, the idea here is to work with your supply chain, to gather as much information as possible, and perform risk assessments. Try not to do chemical analytical testing.

3. RoHS Testing Activities

The conformity assessment is conducted by reviewing the documentation as collected from your providers, for every EEE that must be compatible with any RoHS jurisdictions, worldwide.

Every component and material included in the parts list (or Bill of Materials- BOM) of a product must be assessed at the manufacturer’s source level.

Per IEC 63000, you must consider the likelihood that a material contains a restricted substance and the trustworthiness of your suppliers. To do so, various types of documents can be accepted as proof of compliance, such as certificates of compliance, declarations, filled-in forms, drawing sheets, specifications, etc. It depends on the component or the material that is being assessed. What you ideally want is that all your suppliers commit to RoHS compliance.

In any case, you must make sure that your supporting documentation will enable you to determine the minimum of RoHS information, such as:

The part/material reference: Series or general statements can be accepted under certain conditions.
The RoHS exemptions information: Can you find out without ambiguity if a part is RoHS compliant without exemption? If an exemption is claimed, is it still valid, or has it expired?
The number of covered restricted substances: Does the statement cover 10 RoHS substances or only the first 6 ones?

In doing so, feel free to use the free Enviropass Product Environmental Compliance (EPEC) form for your RoHS compliance inquiries. This form is updated every time a covered regulation is amended.

Your RoHS assessments must be recorded and include all the documents used as evidence. The RoHS compliance system must be maintained over time, and be consistent with your product modifications, redesigns as well as the RoHS regulation updates.

4. The EU RoHS Declaration of Conformity

A product can only be assessed as compliant if all the components and materials are found compliant. If the conclusion of a product assessment shows compliance, then the manufacturer can produce a Declaration of Conformity, also known under the acronym ‘DoC’. The RoHS DoC must follow the EU RoHS Annex VI of Directive 2011/65/EU, and include:

an ID number identifying the product, for example the product’s name and the model’s version.
the legal name and address of the manufacturer;
the following statement: This Declaration of Conformity is issued under the sole responsibility of the manufacturer;
the identification of the product, such as the product description or an image;
the requirements the product complies with;
the date of issue of the DoC;
the signature and title of the authorized person.

Such a RoHS declaration is part of the CE DoC, which is a folder containing all the DoCs associated with one product.

Finally, the DoC must be made available to the surveillance authority upon request. In any case, when a surveillance authority, an importer, or a customer requests a DoC, the manufacturer should provide its up-to-date version, at the time the electronic product was placed into the EU market.

5. Conformity Marking

Every product with a complete technical file and valid DoCs must bear relevant conformity markings according to the risk analysis and product requirements. The marking for a RoHS compliant product is the CE marking. No other marking such as a lead-free, or a RoHS label is permitted, because it may mislead the customer.

Note that the CE marking obligations also cover other directives than the EU RoHS, such as electrical safety requirements. The ‘blue guide on the implementation of EU products rules‘ gives details on how to fully comply with the CE marking requirements.

What Process must be Described in the EU RoHS Procedure?

In a nutshell, the manufacturer must explain the following four actions:

Determine what information is needed
Collect the information
Evaluate the information and decide whether to include it in the product technical documentation or not
Ensure that the technical documentation remains valid

How often should I Reiterate the RoHS Testing Process?

According to article 7 paragraph (b) of the Europe RoHS Directive 2011/65/EU of the European Parliament and of the Council, manufacturers must:

”(…) ensure that procedures are in place for series production to remain in conformity. Changes in product design or characteristics and changes in the harmonised standards or in technical specifications by reference to which conformity of EEE is declared shall be adequately taken into account.”

The product technical file is not static. You should undertake the RoHS testing process anytime a product’s technical file must be updated. It must be updated, whenever:

A new component or a new manufacturer source is created;
A new revision of a purchased designed assembly or part is released. For example, this occurs when materials are changed;
The regulatory risk analysis shows new product requirements or changes in the product requirements. For instance, when a new applicable RoHS exemption expires or a new exemption is created. Or, if a standard like the IEC 63000 is updated, it may also be necessary to update the technical file accordingly.

The product RoHS compliance is likely to change. For example, if an exemption is removed per a RoHS amendment, a new assessment should be conducted. Then, the previous declaration of compliance (DoC) is obsoleted and replaced by the latest version of the DoC, which becomes valid on the date of its signature.

What if a Part is not Fully EU RoHS Compliant?

No RoHS De Minimis

When, one manufacturer source does not provide evidence of compliance for a specific component, then the whole part is assessed as non-compliant. There is no de minimis tolerance threshold here. A component can only be evaluated as compliant if all of its manufacturer sources are found compliant. Also, if a manufacturer source benefits from an exemption, the entire part is also assessed as compliant under that same exemption.

The RoHS Procedure for Corrective Actions

Your RoHS procedure should explain any further actions when a tested product is not EU RoHS compliant. Here are two examples of corrective actions your procedure can detail:

Obsoleting the problematic source‘s components and replacing them if possible;
Modifying the design (materials used) and/or performing a new chemical analysis (analytical test report), specifically for the identified risky homogenous materials, if the component’s source cannot be replaced.

At the last resort, if you decide to undertake analytical RoHS testing on homogeneous material samples, then you should implement a testing plan. In the testing plan, you will determine the type, the number of samples, and the periodicity of the analytical RoHS testing. This undertaking can reveal costly in terms of energy, time, and money. It is recommended to ponder all the options before considering such a testing campaign.

What to do in Case of RoHS Missing Information

This will certainly happen. Imagine the technical documentation you have gathered for a specific parts list shows ambiguous or contradicting information. For instance, you may have collected:

Two separate documents with different valid exemptions for the same manufacturer source; or
Low quality, unreliable RoHS documents, for one reason or another

If the supplier is unable to provide the remaining missing information, then corrective actions, as described above, must be performed.

RoHS Traceability Requirements

This is a key concept when it comes to drafting a RoHS procedure. For example, the RoHS procedure itself will be revised and previous versions should be archived.

Product Identification

Every finished good must bear:

A serial number;
The manufacturer’s name registered trade name;
A contact postal address on the product or when not possible because of its size or physical characteristics (excluding non-esthetical reasons) on its packaging, and/or on the accompanying documentation.

Archiving the RoHS Technical Documentation

According to the EU RoHS directive 2011/65/EU, every element of the technical files should be kept for at least ten years after the last item of a product model was placed on the market. The procedure should reflect this period. Therefore, the manufacturer must keep a ten years record of:

Every revision of the product user guides and datasheets as well as the product assessments and DoCs;
Information on components: This should never be deleted or replaced, even for obsolete components;
Document updates: The new version is added to the older one.

Non-Conformity and Recalls

Every non-conforming EEE and product recall must be registered internally as well. However, if you apply a robust RoHS procedure, product recalls because of a non-RoHS compliant product, should not happen.

Need help with your product environmental compliance or your RoHS procedure? Contact Enviropass!

Environmental Assessment

Environmental Assessment

Environmental Assessment

ROHS COMPLIANCE: THE PROCEDURE

Why an EU RoHS Procedure?

What an EU RoHS Compliance Procedure should Contain

1. Explain how you Monitor your Product Environmental Requirements

2. Set a RoHS Compliance Action Plan

3. RoHS Testing Activities

4. The EU RoHS Declaration of Conformity

5. Conformity Marking

What Process must be Described in the EU RoHS Procedure?

How often should I Reiterate the RoHS Testing Process?

What if a Part is not Fully EU RoHS Compliant?

No RoHS De Minimis

The RoHS Procedure for Corrective Actions

What to do in Case of RoHS Missing Information

RoHS Traceability Requirements

Product Identification

Archiving the RoHS Technical Documentation

Non-Conformity and Recalls