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REACH Regulation 1907/2006 on restrictions of Triton substance use in IVD reagents
EFLM survey on waste management in healthcare settings

The next meeting with the ECHA scientific committees RAS & SEAC is scheduled for the end of October; for this reason, we decided to keep the EFLM survey open till October 15 in order to collect a more representative number of replies from EU contries!

Please, circulate this survey also to other laboratories in your country: the larger number of replies we have, the greater is the possibility to obtain an adeguate timing for the introduction of the new ECHA regulation.

Please access the below survey to answer these 4 very short questions with prefixed options to select:

How is the liquid waste from your analysers currently disposed of?

If not collected for incineration, how would you rate the feasiblity to do so?

If you rated the possibility of incineration as “possibly feasible” or “not at all feasible”, what are your main reasons/concerns?

How many tests per year does your facility perform?
(Immunoassay and Clinical Chemistry)

Click here to access the survey

(only one feedback per device is allowed)

Call for action!
REACH Regulation 1907/2006 on restrictions of Triton substance use in IVD reagents
A realistic approach for Medical Laboratories?

In July 2017, the substance 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (4-tert-OP) and 4-nonylphenol was added to Annex XIV of Regulation (EC) No 1907/2006 (‘REACH Regulation’)[1] with a sunset date of January 4th, 2021. After this date, this substance can no longer be placed on the market or used in the EU unless subject to Authorisation (or exemption).

4-tert-OP and NPE are commonly used substances in the in vitro diagnostic (IVD) medical devices industry to ensure the specificity and sensitivity of diagnostic tests for hundreds of different diseases and conditions. These diagnostic tests are specifically balanced and designed to perform biochemical reactions at the molecular level when combined with patient samples, and re-designing these tests with different substances is an extremely challenging and technical process subject to stringent regulatory requirements including testing, validation and country registrations which can take 5-12 years to complete per product.

Despite entering into the process of Authorisation in good faith, the Draft Opinions prepared by the Risk Assessment Committee (RAC) & Socioeconomic Assessment Committee (SEAC) in regard to the majority of these applications now recommend that Downstream Users are subject to the following conditions:

“All solid and liquid waste shall be collected for adequate treatment. The treatment shall minimize releases to environmental compartments as far as technically and practically possible. Release into the sewer system or to surface waters is not adequate treatment.”

Compliance with these conditions will put the supply of IVD products in the EU at risk, given the significant impacts associated with their implementation.

As EFLM we consider that the proposed conditions are unrealistic and unfeasible for medical labs at this short notice due to technical, logistical and financial constraints. Also, the recommendation will introduce a competitive disadvantage for some applicants and downstream users. The proposed conditions, if implemented, are disproportionate and would pose a serious risk to the continued operation of testing laboratories and as such could result in severe delays in diagnosis and treatment for millions of EU patients. Potential risks to human health as a consequence of the proposed conditions of Authorisation must be given appropriate consideration.

IVD-manufacturers currently ask authorization to enable continuity of IVDs on the European market. If IVD-manufacturers get their authorizations for continued use of these detergents, the conditions for use required by REACH are deviated to the end-users.

The recommended REACH instructions to end-users are: All solid and liquid waste shall be collected for adequate treatment. The treatment shall minimize releases to environmental compartments as far as technically and practically possible. Release into the sewer system or to surface waters is not adequate treatment.”

As there is currently no known treatment technology proven to effectively remove dilute concentrations of 4-tert-OP and NPE from the wastewater generated from reagents used upon IVD instrument platforms, this implies that EU healthcare systems and diagnostic laboratories should collect and incinerate all their wastewater.

[1] Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)


Please note that, as a principle, the obtaining of a REACH Authorisation does not mean that reagents can be supplied in their current form forever.

Authorisations are granted for a time-limited period and, during that time, the suppliers will need to continue actively trying to find and implement alternatives.  When manufacturers can prove to have found alternatives, Authorisations will not be renewed and the reagents can be placed on the market again.

In summary, a REACH Authorisation is a period of time during which the authorities expect the industry to ideally phase out use of the substance.

In the meantime (till 4 January 2021), if Authorisations are not granted, lab professionals could be faced with a prohibition to continue receiving and using the reagents mentioned below.

What to do?

So far, the ECHA scientific committees RAS & SEAC do not understand that their recommendation to end users, at a date that will be specified in the authorization decisions, is not realistic nor feasible, and even harmful for patient care. Therefore, the strategy chosen is to inform the ECHA committees on the disproportionate consequences of their recommendation. To that end, a short survey on the impact of this ECHA recommendation for medical labs has been developed. Assuming that a reasonable amount of information will be gathered from this mini-survey regarding the (non-)feasibility of this recommendation, it is anticipated that ECHA may listen to arguments from laboratory professionals.

Planning of the European Commission: Formal decisions regarding the ECHA authorization process and allowances of IVDs containing Triton-type detergents will be taken by mid-September 2020. Therefore, the EFLM survey on waste management in healthcare settings (only 4 questions!) should preferentially be filled in immediately after reading this communication and/or at latest per 8 September 2020 (now postponed to 15 October 2020). This very short notice should not prevent us from doing the mentioned survey timely!

We thank you in advance for your important contribution!

Click here to read the full EFLM information sheet
European Federation of Clinical Chemistry and Laboratory Medicine

Egmontstraat 11, Brussels


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