REACH is a regulation of the European Union, adopted on 1 June 2007 to protect human health and the environment from risks posed by chemicals.

Under the terms of Title VII of Regulation (EC) 1907/2006 (‘REACH’), two groups of chemical substances have been placed on the list of substance subject to authorization [1]. These substance groups have been described as:

  • 4-(1,1,3,3-tetramethylbutyl) phenol, ethoxylated, covering well-defined substances and UVCB substances, polymers and homologues (OPEs).
  • 4—Nonylphenol, branched and linear, ethoxylated (NPEs).

OPEs and NPEs break down to form endocrine disruptors in the aquatic environment [2,3], which can disrupt the natural balance of hormones, and thus produce adverse effects on aquatic life health.

Beginning 4 January 2021, most uses of these substances (and mixtures containing these substances) within the EEA will be prohibited. However, uses that meet the definition of Scientific Research and Development (SRD) are exempt from Authorization under controlled conditions [4]. Additionally, mixtures which contain less than 0.1% (w/w) OPE and NPEs are considered exempt from the ban.

It is Thermo Fisher Scientific’s mission to enable our customers to make the world healthier, cleaner, and safer. After systematic evaluation certain products were selected for re-formulation to remove OPE/NPEs. As these changes are made, there is no intention to change product part numbers. Products before and after reformulation are differentiated by the Lot Number. Updated Material Safety Data Sheets reflecting the absence of the substances will be available on the product webpages. MSDS for products prior the change may be requested through MSDS request form.

Products receive Lot Numbers in sequential order, therefore, if the Lot Number of your product is equal or larger than Lot Number provided in the table, product has no OPE/NPE substances. Product Lot Number is indicated on the product label (Figure 1).

Thermo Fisher Scientific has conducted extensive studies and QC testing to ensure that removal of OPEs and NPEs have no effect on the overall functional characteristics or stability of the products. As a proof, we prepared data demonstrating performance equivalency of selected products after reformulation.

Please find the searchable list of products SKUs that have been reformulated to remove OPEs and/or NPEs.

Example of a product box with an arrow indicating the lot number information on the product label

Figure 1. Example of product packaging with highlighted Lot Number on the product label.

Reverse Transcription formulations
No records were found matching your criteria
SKUDescriptionUpdated products start from Lot Number*
12594025SuperScript IV One-Step RT-PCR System01167590
12594100SuperScript IV One-Step RT-PCR System01167657
12595025SuperScript IV One-Step RT-PCR System with ezDNase01180697
12595100SuperScript IV One-Step RT-PCR System with ezDNase01272563 
18090010SuperScript IV Reverse Transcriptase1174747
18090050SuperScript IV Reverse Transcriptase1175143
18090200SuperScript IV Reverse Transcriptase1175143
18091050­­­SuperScript IV First-Strand Synthesis System1173111
18091150SuperScript IV First-Strand Synthesis System with ezDNase EnzymeTo be determined
18091200SuperScript IV First-Strand Synthesis SystemTo be determined
18091300SuperScript IV First-Strand Synthesis System with ezDNase EnzymeTo be determined
11756050SuperScript IV VILO Master Mix2704369
11756500SuperScript IV VILO Master Mix2697643
11766050SuperScript IV VILO Master Mix with ezDNase Enzyme2724406
11766500SuperScript IV VILO Master Mix with ezDNase Enzyme2699708
11766051ezDNase Enzyme01166915
AB1453AVerso cDNA Synthesis Kit2579195
AB1453BVerso cDNA Synthesis Kit2575682
K1632RevertAid H Minus First Strand cDNA Synthesis Kit01178621
K1641Maxima First Strand cDNA Synthesis Kit for RT-qPCR01173086
K1642Maxima First Strand cDNA Synthesis Kit for RT-qPCR01164948
K1651Maxima H Minus First Strand cDNA Synthesis Kit01189468
K1652Maxima H Minus First Strand cDNA Synthesis Kit01270458 
K1671Maxima First Strand cDNA Synthesis Kit for RT-qPCR, with dsDNase01167380
K1672Maxima First Strand cDNA Synthesis Kit for RT-qPCR, with dsDNase01157139
K1681Maxima H Minus First Strand cDNA Synthesis Kit, with dsDNase01187283
K1682Maxima H Minus First Strand cDNA Synthesis Kit, with dsDNase01285556 
K1691RevertAid RT Reverse Transcription Kit01273597 
M1661Maxima H Minus cDNA Synthesis Master Mix01114532
M1662Maxima H Minus cDNA Synthesis Master Mix01120143
M1681Maxima H Minus cDNA Synthesis Master Mix, with dsDNase01120849
M1682Maxima H Minus cDNA Synthesis Master Mix, with dsDNase01120636
EP0441RevertAid Reverse Transcriptase01277310 
EP0442RevertAid Reverse Transcriptase01294886 
EP0451RevertAid H Minus Reverse Transcriptase01171388
EP0452RevertAid H Minus Reverse Transcriptase01170128
EP0741Maxima Reverse Transcriptase01178471
EP0742Maxima Reverse Transcriptase01174824
EP0743Maxima Reverse Transcriptase01162712
EP0751Maxima H Minus Reverse Transcriptase01184576
EP0752Maxima H Minus Reverse Transcriptase01277400 
EP0753Maxima H Minus Reverse Transcriptase01276373 
K2561Maxima H Minus Double-Stranded cDNA Synthesis Kit2620552
K2562Maxima H Minus Double-Stranded cDNA Synthesis Kit2572206
K2563Maxima H Minus Double-Stranded cDNA Synthesis KitTo be determined
EN0771dsDNase01167195 
11750150SuperScript IV CellsDirect cDNA Synthesis Kit01312360
11750350SuperScript IV CellsDirect cDNA Synthesis Kit91313070
AB1454LDBVerso 1-Step RT-PCR Kit ReddyMix, with ThermoPrime Taq2574534
K1612First Strand cDNA Synthesis Kit2574774
K1621RevertAid First Strand cDNA Synthesis Kit2580149
K1622RevertAid First Strand cDNA Synthesis Kit2575015
K1631RevertAid H Minus First Strand cDNA Synthesis Kit1174766

* Provided Lot Number is the 1st Lot for which the product was reformulated without OPEs/NPEs. Affected products will be updated on a regular basis.
 

PCR reagents
No records were found matching your criteria
SKUDescriptionUpdated products start from Lot Number*
14000012Platinum II Hot-Start PCR Master Mix (2X)01295573
14000013Platinum II Hot-Start PCR Master Mix (2X)01278242
14000014Platinum II Hot-Start PCR Master Mix (2X)01270597
14001012Platinum II Hot-Start Green PCR Master Mix (2X)91286283
14001013Platinum II Hot-Start Green PCR Master Mix (2X)91285868
14001014Platinum II Hot-Start Green PCR Master Mix (2X)01281226
14966001Platinum II Taq Hot-Start DNA PolymeraseTo be determined
14966005Platinum II Taq Hot-Start DNA PolymeraseTo be determined
14966025Platinum II Taq Hot-Start DNA PolymeraseTo be determined
AB-0301/BThermoprime Plus DNA PolymeraseTo be determined
AB-0575/DC/LD/BReddyMix PCR Master MixTo be determined
B1610X Taq Buffer with KCl and 15mM MgCl2To be determined
B3810X Taq Buffer with KClTo be determined
B6510X DreamTaq Buffer01298781
B7110X DreamTaq Green Buffer01334926
EP0401Taq DNA Polymerase recombinant01321682
EP0402Taq DNA Polymerase recombinantTo be determined
EP0404Taq DNA Polymerase recombinant (1 U/µL)91303857
EP0405Taq DNA Polymerase recombinantTo be determined
EP0406Taq DNA Polymerase recombinant91301621
EP1701DreamTaq Hot Start DNA PolymeraseTo be determined
EP1702DreamTaq Hot Start DNA PolymeraseTo be determined
EP1703DreamTaq Hot Start DNA PolymeraseTo be determined
EP1711DreamTaq Hot Start Green DNA PolymeraseTo be determined
EP1712DreamTaq Hot Start Green DNA PolymeraseTo be determined
EP1713DreamTaq Hot Start Green DNA PolymeraseTo be determined
K0171PCR Master Mix (2X)01195392
K0172PCR Master Mix (2X)01192296
K9011DreamTaq Hot Start PCR Master MixTo be determined
K9012DreamTaq Hot Start PCR Master MixTo be determined
K9021DreamTaq Hot Start Green PCR Master MixTo be determined
K9022DreamTaq Hot Start Green PCR Master MixTo be determined
12351-010Platinum SuperFi DNA PolymeraseTo be determined
12351-050Platinum SuperFi DNA PolymeraseTo be determined
12355-005Platinum SuperFi BufferTo be determined
12356-005Platinum SuperFi Green BufferTo be determined
F-122LPhire Hot Start II DNA Polymerase01268376
F-122SPhire Hot Start II DNA Polymerase01268277
F-124LPhire Green Hot Start II DNA Polymerase01296208
F-124SPhire Green Hot Start II DNA Polymerase01309498
F-130WHPhire Plant Direct PCR Kit2619876
F-1312X Phire Plant PCR BufferTo be determined
F-140WHPhire Animal Tissue Direct PCR Kit2570764
F-1412X Phire Animal Tissue PCR BufferTo be determined
F-150BIDPhusion Human Specimen Direct PCR Kit01271181
F-160LPhire Plant Direct PCR Master Mix2580014
F-160SPhire Plant Direct PCR Master Mix2608054
F-170LPhire Tissue Direct PCR Master Mix2573912
F-170SPhire Tissue Direct PCR Master Mix2588617
F-175LPhusion Blood Direct PCR Master Mix2595121
F-175SPhusion Blood Direct PCR Master Mix01285689
F-518LPhusion HF Buffer Pack01281717
F-519LPhusion GC Buffer Pack01270808
F-524LPhire Reaction Buffer01266450
F-5262X Phusion Blood PCR Buffer2616488
F-527LPhire Green Reaction Buffer01303180
F-530LPhusion High-Fidelity DNA Polymerase01277796
F-530SPhusion High-Fidelity DNA Polymerase01273265
F-531LPhusion High-Fidelity PCR Master Mix with HF Buffer01275015
F-531SPhusion High-Fidelity PCR Master Mix with HF Buffer01271859
F-532LPhusion High-Fidelity PCR Master Mix with GC Buffer2589057
F-532SPhusion High-Fidelity PCR Master Mix with GC Buffer2577002
F-533LPhusion U Hot Start PCR Master Mix01271255
F-533SPhusion U Hot Start PCR Master Mix01273775
F-534LPhusion Green High-Fidelity DNA Polymerase01297605
F-534SPhusion Green High-Fidelity DNA Polymerase01295184
F-537LPhusion Green Hot Start II DNA Polymerase01292122
F-537SPhusion Green Hot Start II DNA Polymerase01295596
F-538LPhusion Green HF Buffer Pack01285829
F-539LPhusion Green GC Buffer Pack01296289
F-541Phusion Site-Directed Mutagenesis Kit01288462
F-547LPhusion Blood Direct PCR Kit2582576
F-547SPhusion Blood Direct PCR KitTo be determined
F-548LPhusion Flash High-Fidelity PCR Master Mix01274338
F-548SPhusion Flash High-Fidelity PCR Master Mix01279575
F-549LPhusion Hot Start II DNA Polymerase01271169
F-549SPhusion Hot Start II DNA Polymerase01280945
F-553LPhusion High-Fidelity PCR Kit01280743
F-553SPhusion High-Fidelity PCR Kit01275187
F-555LPhusion U Hot Start DNA Polymerase91304091
F-555SPhusion U Hot Start DNA Polymerase01292133
F-556LPhusion U Green Hot Start DNA Polymerase01294137
F-556SPhusion U Green Hot Start DNA Polymerase01298545

* Provided Lot Number is the 1st Lot for which the product was reformulated without OPEs/NPEs. Affected products will be updated on a regular basis.
 

Performance comparison data of updated and original formulations

 

Frequently Asked Questions

I have purchased a product with different Lot Number than referred in the table. Does my product contain OPEs/NPEs?

Reverse Transcription reagents receive lot numbers in sequential order. Therefore, if the Lot Number is prior to Lot Number provided in the table, your product has the original formulation containing OPEs/NPEs in its composition and you should ensure you will be able to meet your legal obligations (REACH, EU Waste and Water Framework Directives, local relevant regulations). If the Lot Number is equal or later than Lot Number provided in the table, your product has no OPE/NPE substances.

I am located outside the EEA, how am I affected by the REACH regulation regarding OPEs/NPEs?

The ban on OPEs/NPEs applies only to the EEA nations. If you are going to reintroduce OPE/NPE substances or products containing OPEs/NPEs to the EEA, we advise you to consult with your appropriate regulatory expert to determine your obligations.

I possess an older version of Reverse Transcriptase with OPEs/NPEs. Where should I dispose the reaction mix after use?

Products containing OPEs/NPEs in its composition should be diverted from non-hazardous waste streams. Please refer to the guidance provided in the product’s Safety Data Sheets.

What is the regulation causing all of this?

The EU Regulation (EC) No. 1907/2006 concerning Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) (Ref. 1). These substances were added to Annex XIV (the so called ‘Authorization List’) via the amending Regulation (EU) 2017/999 on 13 June 2017. The regulation set forth a transition time establishing a sunset date of 4 January 2021.

If this happened in 2017…why am I just hearing about it?

The regulation set forth a transition time establishing a sunset date of 4 January 2021.

I’m using DreamTaq DNA Polymerase, when OPE/NPE substances will be replaced in this product?

We are systematically re-formulating the affected products. Until we are able to reformulate DreamTaq products, we are asking our customers to abide by their regulatory obligations to use the R&D product under controlled conditions as described in the product MSDS. As these changes are made, we will notify you by e-mail. In addition, an information card will be included in the product packages informing you about the change.

Where can I find more information about the requirements regarding the use of OPEs/NPEs containing products in different analytical activities?

More information can be found in the Q&A section of the European Chemical Agency page .  We recommend reading ECHA Q&A 585, v1.2 ; ECHA Q&A 1030, v1.2; ECHA Q&A 1442, v1.1 ; and ECHA Q&A 1443, v1.1 .

References

  1. REACH Regulation 
    • Title I, Article 2(5)(a) and (b) – provides the general exemption for certain uses>
    • Title VII, Article 56(4-6) – provides further use exemptions as well as specific exemptions based on substance concentration/hazard combinations
    • Title VII, Article 60(2-3)– provides clarification for use in Medical Devices and In Vitro Diagnostic reagents
    • Title VII, Article 56(3) – describes the exemption for Scientific Research and Development (SRD). This is a very broad exemption extending to IVD, Veterinary Diagnostics, and other laboratory uses.
    • Title VII, Article 57(f) – describes properties of substances to be included in Annex XIV
  1. Identification of NPEs 
  2. Identification of OPEs 
  3. MedTech Europe position paper that describes controlled conditions .

For Research Use Only. Not for use in diagnostic procedures.