REACH Updates and a Comparison to RoHSREACH Updates and a Comparison to RoHS
This primer will help medical device manufacturers that are already familiar with RoHS gain a better understanding of the European Chemical Agency’s REACH legislation.
March 24, 2017
The Importance of Understanding REACH
In February 2017, the European Chemical Agency (ECHA) released a draft guidance on requirements for substances in articles under REACH (Registration, Evaluation, Authorization, Restriction of Chemicals, Regulation (EC) No 1907/2006). REACH is an extremely important (and complex) piece of legislation to understand, but just like RoHS (Restriction of the use of certain Hazardous Substances, Directive 2011/65/E), meeting its requirements is a must to sell products in Europe.
Designing for compliance from day one can reduce the likelihood of changes to product bill of materials (BoMs) during manufacturing--a costly undertaking for medical devices. If medical device designers properly understand REACH during the device design phase, the result will be a faster, cheaper development phase and a better product.
The guidance states in plain language using examples the ECHA's interpretation of the REACH legislative text in conjunction with relevant court ruling(s). In this article, I interpret the guidance from the point of view of a finished goods manufacturer/ importer, specifically for medical devices, who has a solid understanding of RoHS. That makes this article an interpretation of an interpretation for a specific audience, and as such, manufacturers should rely upon the original guidance for exact information. Information regarding chemical registration, upstream vendors, and restricted substances have been mostly excluded here.
ey Conclusion #1--Determining What 0.1% Weight by Weight Applies To
The first conclusion the guidance makes is intended to clarify the responsibility for REACH compliance
"Article 7(2) of the REACH Regulation must be interpreted as meaning that, for the purposes of application of that provision, it is for the producer to determine whether a Candidate List substance of very high concern, is present in a concentration above 0.1% weight by weight of any article it produces and, for the importer of a product made up of more than one article, to determine for each article whether such a substance is present in a concentration above 0.1% weight by weight of that article" (page 3, line 17).
To further clarify: The substance concentration threshold of 0.1% w/w applies to each article as produced or imported. This threshold applies to each article of a complex object. An importer of a complex object is importer of the various articles the complex object is made from, and must therefore have the necessary information for each one of them, for the purpose of being able to comply with notification obligations.
Comparison to RoHS--Both REACH and RoHS set the nominal limit at 0.1% w/w of SVHCs and authorized substances. Be careful though, as RoHS has exceptions allowing higher amounts of substances to be present under certain circumstances and only allowing lower amounts to be present in other circumstances.
Key Conclusion #2--Determining the Notification Responsibilities
The second conclusion the guidance makes is intended to clarify who is responsible for passing information to whom, what information they must pass along, and when they must pass it along.
"Article 33 of the REACH Regulation must be interpreted as meaning that, for the purposes of application of that provision, it is for the supplier of a product one or more constituent articles of which contain(s) a Candidate List substance of very high concern in a concentration above 0.1% weight by weight of that article, to inform the recipient and, on request, the consumer, of the presence of that substance by providing them, as a minimum, with the name of the substance in question" (page 3, line 23).
To further clarify: the supplier is responsible for informing the importer if an article contains one or more substances of very high concern (SVHCs) above 0.1% w/w (by listing each SVHC over the limit).
Comparison to RoHS--RoHS does not require communication obligations in the same way as REACH; they simply require that certain substances not be present.
Defining an Article
A large portion of the guidance is dedicated to describing what an article is and isn't:
Where, an article is "an object which during production is given a special shape, surface or design which determines its function to a greater degree than does its chemical composition (Article 3(3))(page 8, footnote). An article [is further defined as] an object composed of one or more substances or mixtures which were given a specific shape, surface or design during the production process. It may be produced from natural materials, such as wood or wool, or from synthetic ones, such as polyethylene (PE). Most of the commonly used objects in private households and industries are themselves articles, or contain articles, e.g. furniture, clothes, vehicles, books, toys, kitchen equipment and electronic equipment" (page 15, line 10).
To further clarify: basically any component or any finished good is considered an article. A complex object is an object "made up of more than one article" (for example, a binder clip). A very complex object is made up of a number of complex objects (examples include computers, aircraft, etc).
Comparison to RoHS--RoHS only applies to electrical equipment sold in the EU, REACH applies to substances and articles imported into the EU or placed on the market in the EU. As this includes almost everything, packaging is also an object under REACH.
If It's Not an Article, What Is It?
Objects that aren't articles are called substances or mixtures, and they include things like blasting grit, paint, etc. In these cases, the chemical composition is more important to function than the shape, surface, or design, or the object (Chapter 2).
Comparison to RoHS--Unlike RoHS, under REACH an article is an item which in itself has usefulness. For example, a resistor on a PCB is an article (as well as the PCBA), but the semiconductor material that makes up the main part is a substance. RoHS does not differentiate between articles and substances, only mixtures and substances.
Why Does It Matter If Your Item Is an Article or a Substance/Mixture?
Great question, but the answer isn't very exciting. It doesn't seem to be a very important distinction for most objects. Substances are the lowest building blocks as far REACH is concerned, but substances alone, substances in mixtures, and substances in articles must all be assessed for SVHCs. As noted earlier, substances/mixtures aren't the focus of this paper, so this is a very basic summary of them (section 3.1).
Comparison to RoHS--Substances are defined differently in REACH and in RoHS, but often result in the same conclusions and therefore often end up being the lowest level homogenous substances. Articles are defined very similarly between RoHS and REACH.
I hope you're enjoying this article, because it's just going to keep getting more complicated. Here goes: whether or not an article releases substances is relevant to REACH. If an article release substances intentionally (i.e., the release of that substance is an "accessory function"), and the amount of the substance that is partially or fully intended to be released is greater than 1 tonne/year, the substances must be registered with the ECHA, apparently regardless of what that substance is (page 50, line 7). There are many more details in the guidance and a number of exemptions in the legal text. For example, water is ok to release in any amount without registering it.
Get all that? Good, because we're about to double down: if a complex object's sole purpose is to release a substance, such as a perfume bottle, then the complex object should be considered an article containing a mixture, not an article which intends to release substances. Furthermore, if an object releases substances due to wear, tear, or outgassing (where the release does not support the function), that is also not considered intended release. Substances released during production or disposal are also not considered to be intended release. Intended release must be part of the normal or foreseeable conditions of use.
The guidance also describes some best practices and some requirements for keeping documentation. It distills them down to this:
Documentation is required for "article producers who use a substance or mixture in the production of their article . . . Each manufacturer, importer, downstream user and distributor shall assemble and keep available all the information he requires to carry out his duties under this Regulation for a period of at least 10 years after he last manufactured, imported, supplied or used the substance or mixture" (page 22, starting line 17).
Since you should be running a REACH compliance process using a simple tracking tool like a spreadsheet, it should not take a large effort to bring this information together to produce the necessary documentation when needed.
What You Need to Do
First, you need to find if your article/complex object is made up of any substances that are SVHCs, any mixtures that contain SVHCs, or any articles that contain SVHCs over 0.1% w/w. Some evaluation and calculation may be required to determine the weight to weight ratio; see the guidance for some very helpful examples of this (Section 3.2.2).
Comparison to RoHS--Unlike RoHS, an article doesn't need to be broken down into its smallest homogenous subcomponents to calculate the total weight. For example, the REACH guidance specifies that for a painted part, the entire weight of the part is used in the calculation. So, where a paint itself might contain 2% w/w of a SVHC, if it's thinly applied to a heavy object it could drop below the 0.1% w/w threshold, and the finished article might then become REACH compliant.
Second, if any articles or substances in your complex object have one or more SVHCs over 0.1%w/w, and you are producing or importing it, you must communicate that information to your buyer, clearly stating the name of the substance(s) in question and why you are providing that information. Note that any resellers in the EU will simply pass their customers along to you, the producer/importer, for information as required, so in this case your notification system must suit both distributors and customers.
If the above is true and you are importing more than 1 tonne of each SVHC per year, you must also inform the ECHA of each substance. The ECHA will use this information as part of their decision-making process, with the implication being that the more a SVHC is used, the more attention it will get (Section 3.2.2).
The SVHC list gets updated periodically (usually every six months), so an article that is compliant one day may not be compliant the next. There is a grandfathering clause for articles that are already finished: "Notification is not required for a substance in articles which have been produced or imported before the substance has been included on the Candidate List for authorisation" (page 26, line 19). However, it should be clearly stated that an object produced in the past and known to be REACH compliant at the time can be grandfathered, but that exact same device, produced in the future and known to not be REACH compliant cannot be grandfathered. If it's been imported or sold, then it's fine. If it hasn't, it needs to be compliant. It is your responsibility to update your REACH documentation and substitute materials or notify your customers as quickly as possible (you have six months after the date of inclusion on the SVHC list to inform your buyers) (page 49).
How You Might Do It
The guidance also describes some methods to confirm compliance in articles or objects. This is where a good supply chain--integrated early in your development--can save a lot of time. Upstream suppliers should be able to provide information such as Certificates of Conformance and/or materials summaries as needed. Physical testing is also possible, but is typically a large undertaking. The guidance also notes that assemblers should take information from upstream vendors with a grain of salt and carefully consider whether the documentation appears accurate and up to date.
Comparison to RoHS--The typical process for determining RoHS compliance is very similar, though for RoHS you might consider chemical testing for the ten materials of question. This is asking a lot less than the hundreds required for REACH.
Exceptions for Notification (section 3.3)
Exception 1: As we know, a producer or importer of articles is required to notify the ECHA when the article includes SVHCs over 0.1% w/w and exceeds 1 tonne/year. They are also required to notify their downstream customers of the presence of the SVHCs over 0.1% w/w regardless of the import amount. However, substances that are already registered for the same use as the article in question are actually exempt from the registration obligation (but are not exempt from the notification obligation) if the "sameness" can be proven effectively. I'd advise reading the guidance for all the details.
Exception 2: If you can control exposure to the article, including during usage, throughout the article's lifetime, including disposal, then notification of substance requirements is not required. Exposure is further defined as "a producer/importer wanting to demonstrate exclusion of exposure has to ensure that the SVHC on the Candidate List does not come into contact with humans or the environment."
"Justification . . . should be documented so that it can be presented to enforcement authorities on request. Such a justification needs to show that no exposure to humans or the environment takes place during the article service life and the waste stage and could include for example one or more of the following elements (page 45, line 24):
· If the substance is contained in the article by technical means . . . [where] the article is unlikely to be opened or to break leading to a release of the substance, in particular during the waste stage
· If the substance is embedded in the matrix of the article"
The guidance also includes notes about using evidence to justify these conclusions. Both evidence and justification would be typically included in the documentation that is made available to authorities.
Also, as the text puts it "Note that it may require more resources and be more difficult to demonstrate "no exposure" than making a notification" (page 45, line 12).
Now You Know!
Or at least you have an idea of the things you need to know. I'd highly recommend planning to spend a significant amount of time understanding your requirements under REACH and defining your plan to comply with it and RoHS 3 if you want to sell your product in the European Market.
Nigel Syrotuck is a mechanical engineer at StarFish Medical, a medical device design company headquartered in Victoria, British Columbia.
[Image courtesy of STUART MILES/FREEDIGITALPHOTOS.NET]
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