BPA a substance of very high concern – Implications for the Medical Devices Regulation
HCWH Europe welcomes the European Chemicals Agency (ECHA)’s decision (16th June), to classify Bisphenol A (BPA) as a substance of very high concern (SVHC) as part of the REACH process. Including BPA on the SVHC list means that its use may be limited and subject to temporary, renewable authorisation. Additionally the European Commission Regulation (EU) 2016/1179) – 19th July 2016, will take effect on 1st of March 2018, which classifies BPA as a category 1B substance. This classification states it is toxic to reproduction i.e. impacts on human fertility. Both of these decisions will have implications for applying the recently adopted Medical Devices Regulation.
The primary concern with BPA is that it has been shown to play a role in the pathogenesis of several endocrine disorders including female and male infertility, precocious puberty, hormone dependent tumours (such as breast and prostate cancer and several metabolic disorders).1
Yet this synthetic chemical has been used for over 50 years, mainly in the plastics industry. As a result, BPA use is widespread - it is contained in plastics that come into direct contact with food, including plastic packaging and kitchenware, and is present in the inner coatings of canned foods and jar lids. But more importantly to HCWH Europe, BPA is also contained in several medical devices.
Annex I of the 2015 report by the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) – The safety of the use of bisphenol A in medical devices (18 February 2015) identified examples of device with materials derived from BPA, which includes - but is not limited to: catheters for minimally invasive surgery, catheters for cardiac ablation, surgical and cardiovascular instruments, endoscopes, pacemakers, pacemaker catheter systems, and catheter delivery systems.
HCWH Europe’s specific concern is the risk of exposure to BPA via such medical devices that can potentially leach BPA via various routes of exposure: oral (via dental material), subcutaneous, or intravenous (e.g. during heamodialysis).
This is probably why SCENIHR concluded in 2015 that whilst: “…the benefit of medical devices has also to be considered, the SCENIHR recommends that, where practicable, medical devices that do not leach BPA should be used. The possibility of replacing BPA in these products should be considered against their efficiency in the treatment, as well as the toxicological profile of the alternative materials”.2
This was in itself an implicit acknowledgment of the potential hazards of BPA in medical devices. But the ECHA decision on 16th of June 2017 is less equivocal than the SCENIHR recommendation, classifying BPA as a substance of very high concern. This decision is a result of a submission by the French Agency for Veterinary Medicinal Products (ANSES) – the Competent Authority in France for risk assessment and management with regard to veterinary medicinal products.
ANSES also previously submitted a proposal to ECHA for amending the classification of BPA in order to include it in category 1B - substances toxic to reproduction. This proposal was adopted by the European Commission in July 2016 and will come into force on 1st of March 2018.
The question then for HCWH Europe is how these decisions will help and assist in the proper application of the Medical Devices Regulation. In this Regulation there is a provision encouraging substitution of harmful chemicals with safer alternatives. Annex I.II.10.4.1, of the Medical Devices Regulation includes a 0.1% concentration limit for category 1A and 1B carcinogenic, mutagenic, and reprotoxic (CMR) substances and endocrine disrupting chemicals (EDCs) in medical devices that are invasive and come into direct contact with the body. Within Annex I of the 2015 SCENIHR Report, we see there are several medical devices containing BPA. Such devices will in the future only be permitted to contain BPA at a level above this limit, if a justification is provided to the notified body, which is overseen by the national competent authority.
It is still early in the process, as member states have three years to implement the Regulation, but it is clear that this decision challenges manufacturers – their medical devices will have to stand the test of scrutiny, as there may be safer alternatives to existing medical devices containing excessive levels of BPA. Equally challenging is the situation of notified bodies who will have to adjudicate on whether alternatives exist.
HCWH Europe therefore welcomes this decision as it paves the way for a challenging review and stock-taking of current medical devices. This decision fits within the provisions of the Medical Devices Regulation and the EU’s broader policies where substitution of harmful chemicals is encouraged under REACH.
- Philippe Vandendaele, Chemicals Policy Advisor - HCWH Europe
Background and further reading
In February 2017, ANSES submitted a proposal to the European Chemicals Agency (ECHA) to classify Bisphenol A (BPA) as a substance of very high concern (SVHC) within the framework of the European REACH Regulation, based on its “endocrine-disrupting” properties - which cause probable serious effects to human health. This proposal has just been adopted by ECHA’s Member State Committee – this decision means that industry must notify ECHA of the presence of Bisphenol A in all imported or manufactured items and must also inform buyers when items contain the substance. The inclusion of BPA on ECHA’s list of substances of very high concern also means that it may be submitted to authorisation as a substance, with its uses subject to the granting of a temporary, renewable authorisation.
ECHA Press Release – 17/06/2017
The safety of the use of Bisphenol A in medical devices (18/02/2015) – SCENIHR
Commission Regulation (EU) 2016/1179 of 19/07/2016 – BPA classification in category 1B
Regulation (EU) 2017/745 – Medical Devices Regulation
(1) Giulivo M, Lopez de Alda M, Capri E, Barceló D (2016). "Human exposure to endocrine disrupting compounds: Their role in reproductive systems, metabolic syndrome and breast cancer. A review". Environ. Res. (Review). 151: 251–264.