Manta Ray - REACH/RoHS Quiz

Choose all that apply. The purpose of the RoHS Directive is to:

• Ensure a high level of protection of human health and the environment.

• Restrict certain substances from being used in any amount for all products and materials imported into the EU.

• Prevent risks posed by and provide for the environmentally sound recovery of electrical waste.

Answer explanation

The RoHS Directive was enacted for the purpose of protecting human health and the environment from hazardous substances present in electrical and electronic products. While the directive imposes restrictions on certain substances, those restrictions do allow for the substances to still be present in an electronic product but only up to a certain percentage by weight.

Choose all that apply. The purpose of the REACH Regulation is to:

• Ensure a high level of protection of human health and the environment.

• Provide a framework for the assessment of hazards of substances.

• Address the production and use of dangerous chemical substances, mixtures, and their use in articles.

Answer explanation

While both RoHS and REACH are aimed at protecting human health and the environment, the scope of the REACH Regulation is broader than RoHS and impacts almost every product made in or imported into the EU. REACH applies to both raw chemical substances as well as substances contained within articles. It requires companies importing or manufacturing these substances to register chemicals with the ECHA and to prove that the chemicals can be used safely. Certain substances under REACH may be fully banned, restricted, or may be subject to prior authorization in order to be used.

Select which product lines are in scope of the RoHS directive:

• GlideLight

• LLD

• Turbo-Power

• Turbo-Elite

• Philips Laser System

Answer explanation

Only 'electrical and electronic products' (EEE) are in scope of RoHS. A product must be dependent on electric currents or electromagnetic fields to function in order to be subject to the RoHS Directive. Therefore, products like ELCA, GlideLight, Turbo-Elite, LLD, and the Quick products are not in scope, whereas PLS, CVX, and Turbo-Power are subject to RoHS requirements in the EU.

True or False?

The European Union is the only region with RoHS requirements.

• True

• False

Answer explanation

A number of countries including China, Japan, Korea, India, Russia, and even California in the US have adopted their own versions of RoHS requirements. In a majority of cases, the EU requirements represent the most restrictive version as other geographies may have narrower scope in terms of the product categories covered and the list of substances that are restricted. However, some geographies (such as China) do have additional requirements around labeling or notification of restricted substances and should be evaluated.

REACH has three different lists of regulated chemicals, each representing a different level of potential harm those chemicals pose. These lists are referred to as the:

• Hazardous Substances List; Candidate Hazardous Substances List; and Cleared Substances List

• Substances of Very High Concern List; Substances of Some Concern List; and Substances of No Concern List

• Restricted List; Authorization List; and Substances of Very High Concern List

• Persistent and Bioaccumulative Substances List; Endocrine Disrupting Substances List; and Carcinogenic and Mutagenic Substances List

Answer explanation

REACH has three different lists of regulated chemicals, each with their own set of restrictions, exemptions, and obligations. They are the:

·         Restricted List: If a substance is on this list, it is known to be harmful and cannot be used in products in the ways the list specifies.

·         Authorization List: If a substance is on this list, it is known to be harmful and should not be in products. However, a manufacturer can get authorization to use a substance on this list by showing there is no safer alternative.

·         Substances of Very High Concern List (SVHC List): If a substance is on this list, there is reason to believe it may be harmful, but the evidence is not yet conclusive. Any substance on this list can be used in any product; but manufacturers, importers and distributers have an obligation to know and disclose the content of SVHCs in their products.

True or False?

X-ray fluorescence (XRF) testing can be used to screen for all materials currently restricted under RoHS.

• True

• False

Answer explanation

XRF can be used for screening the original 6 restricted substances but cannot detect the 4 phthalates added in RoHS3. Testing for phthalates can be done by first extracting the compounds with a solvent and then analyzing the extraction using gas chromatography coupled with mass spectrometry or flame ionization detection.

Do the REACH limits still apply to a medical device if a manufacturer imports less than 1 ton of that particular device per year?

• Yes

• No

• It depends

Answer explanation

The 1-ton limit is for registration of chemicals only and does not apply to articles or devices imported into the EU.

The list of restricted substances in the RoHS directive is updated by the Commission on as as-needed basis, whereas the REACH Candidate list of ‘Substances of Very High Concern’ is updated how often?

• Twice a year

• Yearly

• Every two years

Answer explanation

Compliance to REACH and RoHS requirements should be re-evaluated periodically to ensure continued compliance. This is especially important for REACH where the Candidate List of SVHCs is updated as often as every six months. Once a substance has been included in the Candidate list, any supplier of articles containing the substance may be required to notify and provide safety information to the recipient or consumer about the substance.

Which of the following are acceptable forms of evidence for demonstrating a material’s compliance with RoHS?

• Supplier declarations and/or contractual agreements

• Material declarations

• Analytical test results

• Only analytical testing performed by the manufacturer of the finished product is sufficient for demonstrating RoHS compliance.

• A, B, and C

Answer explanation

Declarations and agreements from suppliers are acceptable forms of evidence, in addition to analytical testing. A risk-based approach may be used to determine the level of documentation needed for a component, by applying technical judgement as whether a certain substance is likely to be contained in a material. In addition, the trustworthiness of a supplier may also be taken into consideration based on historical experience with the supplier or results of previous inspections or audits. For example, on CVX a non-compliant component was found from cable manufacturer, Belden. Upon discovery of this non-compliance, all components from this supplier were considered to be suspect and were tested rather than accepting supplier/material declarations from Belden as had been previously relied upon.

Under RoHS, the maximum allowable concentration of the restricted substances applies at what level of a product’s Bill of Materials?

• Concentration of restricted substance vs. weight of all products imported by a manufacturer in a given year

• Concentration of restricted substance vs. weight of finished device

• Concentration of restricted substance vs. weight of component or assembly

• Concentration of restricted substance vs. weight of homogeneous materials

Answer explanation

The restricted substance limits apply to the concentration by weight of the substance in ‘homogeneous materials’. The definition of ‘homogeneous material’ in RoHS is: “one material of uniform composition throughout or a material, consisting of a combination of materials, that cannot be disjointed or separated into different materials by mechanical actions such as unscrewing, cutting, crushing, grinding and abrasive processes”.

In short, the concentration limits apply at the ‘lowest mechanically separable’ material. For example if you have a metal panel that is coated in a paint, the concentration limit applies separately to the paint and to the metal panel and not to the combined weight of the panel plus the paint.