Document RaR7bb1DLq5NNn82Vw0NMjVB

Ref. Ares(2021)6233449 - 13/10/2021 REACH) DG Internal Market, Industry, Entrepreneurship and SMEs, European Commission Avenue d'Auderghem, 45 1040 Bruxelles B^egistered mail and e-mail : |^^).. GROW-Dl@ec.europa.eu DG Environment Avenue de Beaulieu, 9 1160 Bruxelles By registered mail and e-mail: ENV-POP@ec.europa.eu Object: PEOA ban - Request for derogation for IVD products Dear Dear We, DIAsource Immunoassays, are an IVD company located in Louvain-la-Neuve Belgium. We are de veloping, manufacturing, and selling worldwide (including Europe) in-vitro diagnostics products for the diagnosis and follow-up of multiple diseases. We are writing to you in your capacity POP Regulation respectively, for the following reasons. n charge of the REACH Regulation and the 1. One of our products portfolio uses PEOA as a critical component to perform an accurate diag nosis of vitamin D deficiency (See Appendix 1 for more information on our products - what they are used for - how they are used - the use of PFOA in these products). As you might know, vitamin D deficiency is an important public health concern that has emerged as a pandemic because low levels of vitamin D in the blood are a risk factor for several chronic disabling disorders, including rickets, osteoporosis, cardiovascular diseases and cancers. Moreover, it is the most undermined, underdiagnosed and undertreated nutritional deficiency. Worldwide, about 1 bil lion people are estimated to have insufficient levels of vitamin D. Up to 70% of the European popula tion suffers from Vitamin D deficiency, with different situations across countries. An accurate diagno sis and monitoring of vitamin D deficiency is therefore a critical health concern nowadays. 2. By a regulation 2017/1000 of 13 June 2017, the European Commission has incorporated PFOA into Annex XVII of the REACH Regulation. As a result, PFOA: shall not be manufactured, or placed on the market as a substance on its own from 4 July 2020;  shall not, from 4 July 2020, be used in the production of, or placed on the market (i) as a part of another substance, as a constituent, (ii) in a mixture or (iii) in an article, in a concentration equal to or above 25 ppb of PFOA including its salts or 1000 ppb of one or a combination of PFOA-related substances. However, according to Article 67.1 of the REACH regulation, these restrictions shall not apply to the manufacture, placing on the market or use of a substance in scientific research and development (hereafter "SR&D"). According to ECHA's Q&A 1442 (of 3 October 2018), the use of an Annex XIV substance when it is required, on its own or in a mixture, as part of an in vitro diagnostic (IVD) method (e.g. in a reagent, calibrator, control material or kit) is considered as scientific research and development and is there fore exempt from authorisation requirements if this activity is carried out under controlled conditions and in a volume not exceeding one tonne per year per legal entity. This interpretation is also confirmed by ECHA's Q&A 585 (of 3 October 2018)1. The Guidance on Scientific Research and Development (SR&D) and Product and Process Orientated Research and Development (PPORD) of 11 December 2017 also states the following (on page 7): "REACH defines scientific research and development (SR&D) as any scientific experimentation, analysis or chemical research carried out under controlled conditions in a volume less than 1 tonne per year (Article 3(23) of the REACH Regulation). Examples of SR&D may include ony experimental research or analytical activities at a labora tory scale such as synthesis and testing of applications of chemicals, release tests, etc. as well as the use of the substance in monitoring and routine quality control or in vitro diagnostics at a laboratory scale under controlled conditions." Furthermore, point 3 (c) of entry 68 of Annex XVII of the REACH Regulation provides that points 1 and 2 of the same entry (which define the restrictions applying to PFOA) shall only apply from 4 July 2032 to "medical devices other than implantable medical devices within the scope of Directive 93/42/EEC'. In this respect, please note that our products do not qualify as implantable medical devices covered by the above-mentioned directive. 3. On 7 November 2019, the European Commission proposed a delegated act to amend the EU POPs Regulation with regard to PFOA, as a follow-up of an agreement reached at international level by the Conference of the Parties to the Stockholm Convention. This delegated regulation proposes to amend Annex I to the POPs Regulation by including PFOAs. The amendment shall apply from 4 July 2020 onwards. According to Article 3 of the POPs Regulation, the production, placing on the market and use of sub stances listed In Annex I, whether on their own, in preparations or as constituents of articles, shall be prohibited. However, Article 3 of the same regulation states that Article 3 shall not apply in the case of "a substance usedfor laboratory-scale research 1 Q&A 585 and 1442 concern, in fact, Article 56 3 of the REACH Regulation which provides for an exception (also relating to SR&D activities) to the obligation to obtain an authorization to use substances listed in Annex XIV. However, we note that in Q&A 1304 (of 2 June 2017) relating to Article 67 of the REACH Regulation, ECHA itself considers that "the same approach can be broadly considered as applicable" for the exceptions referred to in Article 56 and those listed in Article 67 of the REACH Regulation. Moreover, the concept of SR&D in these two articles is defined in the same way by Article 3(23) of the REACH Regulation. Therefore, the concept of SR&D has to be Interpreted in the same way under Article 56 and Article 67 of the REACH The concept of laboratory-scale research is not defined by the POPs Regulation but should certainly be given a similar interpretation to the one given to the concept of research under the REACH Regu lation. 4. The fact that our products are solely manufactured, distributed and used by professionals, and are therefore never exposed to the public population, reduces the risk of contamination of the public. Moreover, the quantities used by our company are very limited in comparison to the other uses of PFOA, namely less than 1.5kg per year. This very fact clearly justifies the exemption under the Reach and POPs Regulations. 5. In view of the above, our company would like confirmation from your part, stating that: With regard to the REACH Regulation: o our products benefit from the exemption provided for SR&D activities; o in any case, our products are medical devices covered by the exemption referred to in point 3 (c) of entry 68 of Annex XVII; With regard to the POPs Regulation: o our products benefit from the exemption provided for substances used for laboratory scale research. We would be grateful if you could get back to us on these points as soon as possible. 6. This being said, we understand the decision to restrict the manufacture, the placing on the mar ket and the use of a product such as PFOA. Although our products are exempt from the REACH and POPs Regulations, our company is committed to removing PFOA from our products as quickly as possible. Our company is making every possible effort to find a credible alternative to PFOA and consequently have it validated and registered by the competent health authorities. Our R&D scientists, regulatory affairs specialists and production teams are working hard to achieve a breakthrough in the short and/or medium term. Given the importance of our products to public health, you will understand that, in the meantime, our company cannot stop the provision of Vitamin D assays for the diagnosis and monitoring of Vitamin D deficiency across the population. Last year, DIAsource Immunoassays has supplied hundreds of hos pitals and clinical laboratories2, for a total number of 1.825 million vitamin D tests. Moreover, Vitamin D assays are poorly standardized, which means that these hospitals and clinical laboratories cannot easily switch from our assays, to other assays available on the market. This requires a long and exten sive validation process, especially keeping in mind the follow-up of patients, which can take up several years. Therefore, the sudden interruption in the provision of our products to the clinical community would have a major impact on the public health with the impossibility to diagnose vitamin D deficiency across a large number of patients, and with the interruption of the monitoring of patients that benefit from a treatment following an initial diagnosis performed with our products. 2 Exact numbers are hard to collect as we supply a large part of our products to distributors, which themselves supply the hospitals and clinical laboratories. Such sudden interruption would be avoided in the case where DIAsource Immunoassays is allowed to continue its supply of PFOA-containing Vitamin D assays while working on the development and vali dation of assays that do not contain PFOA. 7. We sincerely thank you for your attention to this letter. We are of course at your disposal for any further information you may require. A copy of this letter is addressed to the European Chemicals Agency. Furthermore, we are available to meet you if you wish, if necessary by conference call (for example through Skype or any other means of online communication...). Sincerely yours, DIASOURCE ImmunoAssays S.A. Rue du Bosquet, 2 B-1348LOUVAIN-LA-NEUVE (BELGIUM) RPM T.V.A. BE 0457 934 723 Appendix 1 DIAsource immunoassays is a manufacturer of in-vitro diagnostic products (IVDs). These products are used by private and hospital clinical laboratories to analyse blood samples from patients, in order to quantify a number of hormones or proteins. The results of these analyses are used by clinicians to diagnose and monitor certain diseases, and take actions accordingly towards the patients. The products concerned by the ban on PFOA are dedicated to the analysis of vitamin D in blood sam ples, in order to evaluate and monitor vitamin D deficiency in patients3. As explained above, vitamin D deficiency is an important public health problem that has emerged as a pandemic because low levels of vitamin D in the blood is a risk factor for several chronic disabling disorders, including rickets, osteoporosis, cardiovascular diseases and cancers. Moreover, it is the most undermined, underdiagnosed and undertreated nutritional deficiency. Worldwide, about 1 bil lion people have been estimated to have insufficient levels of vitamin D. Up to 70% of the European population suffers from Vitamin D deficiency, with different situations across countries. An accurate diagnosis and monitoring of vitamin D deficiency is therefore a critical health concern nowadays. Our products meet these needs by providing a reliable solution to the clinical community. PFOA, in these products, has a critical role in allowing the quantification of vitamin D from the blood sample, it acts as a kind of sample treatment. Removing PFOA from the products simply prevents the measurement of vitamin D in these samples. The role of PFOA in our products is very different from the classical use of PFOA as a surfactant for many industries. 3 See below an extract of the insert of two of the products concerned by PFOA. The complete versions and portfolio of products can be found on our website: httos://www.diasoiirc-diagnostics.com/IVD-Products/lmmunoAssays/Bone-Metabolism/Vitamin-D. C US: For in-vitro diagnostic use only. Read mtire poroed before ce. 25OH Vitamin D Total ELISA L INTENDED USE hxummoenzymetric assay far the in vio-o quantitative measnreruLni of ? 5-hyrlrnxyvitamm D2 and (25O-D2 and 25OH-D3) in . GENERAL INFORMLJON A Proprietary name j DIAwinre 25OH Vitenizi D Total ELISA Kit B. Catalog number : KAP1971 :96 tes C. Manufactured by : DIAsource ImmunoAssays SA Rne du Bosquet, 2 B-134S Louvam-la Neuve, Belgium. For technical assistance or ordering information contact : Td : +32 (0)10 84 99 U Fax :+32 (0)10 84 99 90 CLINICAL BACKGROUND Vkmom is the generic tenu used to designate Vitnnin D2 or Kgooloferol and Viramia D3 or cholecaldfeoL Hnmarn naturallyprodire \gnun 3 when foe skinis espawd to ultraviolet ranrays. In foe hver mainly, Vitamin D3 is abolised imo ?S-Hyriroxy-Lit D3 (25H D3) which is fos n^in fonn af Viennin D riTrul-qtrng m the body. 25OHD3 is a precursor for otherVitsaanD metabolites andhas also a limitedactivity by itself The- most active derivative is lJ5-hvdroxyrriianan D3, produced in the kidney (ar placenta) bv l-hydrnrylstion of 25OH3. 25OH Vinmin D stinmlates die nnesrnal absorption of both calcium and phosphorus and also bone rescipuon and ann ralisanom 25OH \ D mlgr also ba xve in other tissue responsible far calunni rraaspatt (place-mil, kidney, mamntaiy dand...) and endooine g^nd (prativrcid beta cgllj,. Viranin 3 and VmtnnD2 are also avableby iesccu through food or dietary bupp'.enntanan_ As \"2 D2 is metabolised in a smular way to Vitamin D3. both cmiibire to e overall Vitamin D status of an indivuinaL It is the reason why it is vniy mspetzni to measure both forms ci 2502Vitamin D equally for a cerreti diagnosis cf Vhcrnrn D deficiency, usnldency or iinoxicaricLL Vitein D deficiency is m importen nik factor for rickets, osteomalada, senile oseoporisis. cancer and pregnan^ oirxoms. The ?suremani of bofo 25OH Vitamin D fonus is also required to daennuiB foe emse of nbncrmal seram calcium concenirauaiis in . C en Read entire protocd beforeuse. 25OH Vitamin D total -RIA-CT INTENDED USE Riidionnzmmoassdy for the in vitro quantitative meLsurezneni of ?5-hydTr>\-yvitnnn D3 and D2 (250H-D3 and 25-OH-D2 ) in . GENERAL INFORMATION A. Proprietar) name : DIAsource 25OH Vitamin total -RIA-CT Kit B. Catalog number : KIP 1971 KIP 1974 : 96 teste :4x 96 teste G XLicufnccured by : DIAsource ImrnunoAssays SA Rue du Bosquet 2.1348 Louvsin-La-Neuve, Bel pium For technical assistance or ordering inforaatien contact : Tel : 4-32 (0) 1 84 99 CO Fax : +32 (0) 10 84 99 90 . CLINICAL E4CKGROVND VinminD is the potorie tene nsed to deimare Vinae3 cc chaleolciforo and Vkarrjn D2 cceaxdoferol produce Vfcurin D3 nten ite skin a exposed io ulnari-t rjn mi n the rermml/. Vtam D3 maaboh^dinto 25Pyrimvyrinmn DJ (25 OH DJ) wtuli the minfonu: cfVitamin rimiWingin the hody. 25 OHDJ is a nreenner foi ctba Vkmn D ^^ andh also a liniired arriruyby tel l- nasi acmedervmw 1^S-BydronjvitsafoiDJ. produced n thekidney( pircara) by 1 a-liydnrsyinnn of25OHD3. 25OHViznin D jtnaJate themiesimaiabsppnn ofbctii phasporas nialsobote aedicneralistftfoL. 2SOHfemn D might also be acrise hi ots risvaw responsMe fortranat (.Vdrpy. zhni...) and endocrine gland (aaraiiaid elands, bra ceL...). ViQmin D3 andVitaminD2 are also availableby iny*maninw food nrHrotary auppLEnumtsrion As VmnirD2 iscisbclsad m a rimila to timm D3. bodiccctribureto itsoverall D sorb of an miridnaL It is tne.whyit nopmam to both forms of25 OHVimTM eqnalh fora career aetois ofXitannn D defoifflcy. esnffiaexycr forosicznon. '. -risuy ir aninoitntiLk frrterfoi artes. saale osteopaiw. ferraran . lbe Kaasuaraitofbodi25 OHVfrurnfo d fon?; also required to derarefoe the emseofabnonral saum oldin cfixeoratfons in parienB. XHtaimn D inmricatiotihas been shownto c.ni^Jriifon and tissue dansg.