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.

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 ezDNaseTo be determined
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 MixTo be determined
11756500SuperScript IV VILO Master MixTo be determined
11766050SuperScript IV VILO Master Mix with ezDNase EnzymeTo be determined
11766500SuperScript IV VILO Master Mix with ezDNase EnzymeTo be determined
11766051ezDNase EnzymeTo be determined
AB1453AVerso cDNA Synthesis KitTo be determined
AB1453BVerso cDNA Synthesis KitTo be determined
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 KitTo be determined
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 dsDNaseTo be determined
K1691RevertAid RT Reverse Transcription KitTo be determined
M1661Maxima H Minus cDNA Synthesis Master MixTo be determined
M1662Maxima H Minus cDNA Synthesis Master MixTo be determined
M1681Maxima H Minus cDNA Synthesis Master Mix, with dsDNaseTo be determined
M1682Maxima H Minus cDNA Synthesis Master Mix, with dsDNaseTo be determined
EP0441RevertAid Reverse TranscriptaseTo be determined
EP0442RevertAid Reverse TranscriptaseTo be determined
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 TranscriptaseTo be determined
EP0753Maxima H Minus Reverse TranscriptaseTo be determined
K2561Maxima H Minus Double-Stranded cDNA Synthesis KitTo be determined
K2562Maxima H Minus Double-Stranded cDNA Synthesis KitTo be determined
K2563Maxima H Minus Double-Stranded cDNA Synthesis KitTo be determined
EN0771dsDNaseTo be determined
11750150SuperScript IV CellsDirect cDNA Synthesis KitTo be determined
11750350SuperScript IV CellsDirect cDNA Synthesis KitTo be determined
AB1454LDBVerso 1-Step RT-PCR Kit ReddyMix, with ThermoPrime TaqTo be determined
K1612First Strand cDNA Synthesis KitTo be determined
K1621RevertAid First Strand cDNA Synthesis KitTo be determined
K1622RevertAid First Strand cDNA Synthesis KitTo be determined
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.
 

No records were found matching your criteria
SKUDescriptionUpdated products start from Lot Number*
14000012Platinum II Hot-Start PCR Master Mix (2X)To be determined
14000013Platinum II Hot-Start PCR Master Mix (2X)To be determined
14000014Platinum II Hot-Start PCR Master Mix (2X)To be determined
14001012Platinum II Hot-Start Green PCR Master Mix (2X)To be determined
14001013Platinum II Hot-Start Green PCR Master Mix (2X)To be determined
14001014Platinum II Hot-Start Green PCR Master Mix (2X)To be determined
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 BufferTo be determined
B7110X DreamTaq Green BufferTo be determined
EP0282Taq DNA Polymerase, native, without BSATo be determined
EP0401Taq DNA Polymerase recombinantTo be determined
EP0402Taq DNA Polymerase recombinantTo be determined
EP0404Taq DNA Polymerase recombinant (1 U/µL)To be determined
EP0405Taq DNA Polymerase recombinantTo be determined
EP0406Taq DNA Polymerase recombinantTo be determined
EP0701DreamTaq DNA PolymeraseTo be determined
EP0702DreamTaq DNA PolymeraseTo be determined
EP0703DreamTaq DNA PolymeraseTo be determined
EP0704DreamTaq DNA PolymeraseTo be determined
EP0705DreamTaq DNA PolymeraseTo be determined
EP0711DreamTaq Green DNA PolymeraseTo be determined
EP0712DreamTaq Green DNA PolymeraseTo be determined
EP0713DreamTaq Green DNA PolymeraseTo be determined
EP0714DreamTaq Green DNA PolymeraseTo be determined
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)To be determined
K0172PCR Master Mix (2X)To be determined
K1071DreamTaq PCR Master Mix (2X)To be determined
K1072DreamTaq PCR Master Mix (2X)To be determined
K1081DreamTaq Green PCR Master Mix (2X)To be determined
K1082DreamTaq Green PCR Master Mix (2X)To be determined
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
AB-1454/LD/BVerso 1-Step RT-PCR Kit ReddyMixTo 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 PolymeraseTo be determined
F-124SPhire Green Hot Start II DNA PolymeraseTo be determined
F-130WHPhire Plant Direct PCR KitTo be determined
F-1312X Phire Plant PCR BufferTo be determined
F-140WHPhire Animal Tissue Direct PCR KitTo be determined
F-1412X Phire Animal Tissue PCR BufferTo be determined
F-150BIDPhusion Human Specimen Direct PCR Kit01271181
F-160LPhire Plant Direct PCR Master MixTo be determined
F-160SPhire Plant Direct PCR Master MixTo be determined
F-170LPhire Tissue Direct PCR Master MixTo be determined
F-170SPhire Tissue Direct PCR Master MixTo be determined
F-175LPhusion Blood Direct PCR Master MixTo be determined
F-175SPhusion Blood Direct PCR Master MixTo be determined
F-518LPhusion HF Buffer PackTo be determined
F-519LPhusion GC Buffer Pack01270808
F-524LPhire Reaction Buffer01266450
F-5262X Phusion Blood PCR BufferTo be determined
F-527LPhire Green Reaction BufferTo be determined
F-530LPhusion High-Fidelity DNA Polymerase01277796
F-530SPhusion High-Fidelity DNA Polymerase01273265
F-531LPhusion High-Fidelity PCR Master Mix with HF BufferTo be determined
F-531SPhusion High-Fidelity PCR Master Mix with HF BufferTo be determined
F-532LPhusion High-Fidelity PCR Master Mix with GC BufferTo be determined
F-532SPhusion High-Fidelity PCR Master Mix with GC BufferTo be determined
F-533LPhusion U Hot Start PCR Master Mix01271255
F-533SPhusion U Hot Start PCR Master Mix01273775
F-534LPhusion Green High-Fidelity DNA PolymeraseTo be determined
F-534SPhusion Green High-Fidelity DNA PolymeraseTo be determined
F-537LPhusion Green Hot Start II DNA PolymeraseTo be determined
F-537SPhusion Green Hot Start II DNA PolymeraseTo be determined
F-538LPhusion Green HF Buffer PackTo be determined
F-539LPhusion Green GC Buffer PackTo be determined
F-541Phusion Site-Directed Mutagenesis KitTo be determined
F-547LPhusion Blood Direct PCR KitTo be determined
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 PolymeraseTo be determined
F-555SPhusion U Hot Start DNA PolymeraseTo be determined
F-556LPhusion U Green Hot Start DNA PolymeraseTo be determined
F-556SPhusion U Green Hot Start DNA PolymeraseTo be determined
K1361MuSeek Library Preparation Kit, Illumina compatibleTo be determined

* 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

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.

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.

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.

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.

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

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.

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.