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 Reverse Transcription reagents after reformulation.

Please find below the 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
Product area SKU Description Updated products start from Lot Number*
Reverse Transcription 12594025 SUPERSCRIPT IV 1-STEP SYSTEM 25 RXN To be determined
Reverse Transcription 12594100 SUPERSCRIPT IV 1-STEP SYSTEM 100 RXNS To be determined
Reverse Transcription 12595025 SUPERSCRIPT IV 1-STEP SYSTEM 25 RXNS To be determined
Reverse Transcription 12595100 SUPERSCRIPT IV 1-STEP SY DNASE 100 RXNS To be determined
Reverse Transcription 18090050 SUPERSCRIPT IV 10,000 units To be determined
Reverse Transcription 18090200 SUPERSCRIPT IV 4 x 10,000 units To be determined
Reverse Transcription 18091050 SUPERSCRIPT IV 1ST STRND SYSTM 50 reactions To be determined
Reverse Transcription 18091150 SSIV SYSTEM WITH EZDNASE 50 RXNS To be determined
Reverse Transcription 18091200 SUPERSCRIPT IV 1ST STRND SYSTM 200 reactions To be determined
Reverse Transcription 18091300 SSIV SYSTEM WITH EZDNASE 200 RXNS To be determined
Reverse Transcription 11756050 SUPERSCRIPT IV VILO MASTERMIX 50 RXNS To be determined
Reverse Transcription 11756500 SUPERSCRIPT IV VILO MASTERMIX 500 RXNS To be determined
Reverse Transcription 11766050 SSIV VILO MASTERMIX W/ EZDNASE 50 RXNS To be determined
Reverse Transcription 11766500 SSIV VILO MASTERMIX W/ EZDNASE 500 RXNS To be determined
Reverse Transcription 11766051 ezDNase Enzyme To be determined
Reverse Transcription AB1453A VERSO CDNA KIT EA To be determined
Reverse Transcription AB1453B VERSO CDNA KIT EA To be determined
Reverse Transcription AB1454LDB VERSO 1-STEP RT-PCR REDDYMIX KIT To be determined
Reverse Transcription K1612 FIRST STRAND CDNA SYNTH KIT EA To be determined
Reverse Transcription K1621 REVERTAID 1ST CDNA SYNTH KIT EA To be determined
Reverse Transcription K1622 REVERTAID 1ST CDNA SYNTH KIT EA To be determined
Reverse Transcription K1631 REVERTAID H MINUS 1ST CDNA KIT EA To be determined
Reverse Transcription K1632 REVERTAID H MINUS 1ST CDNA KIT EA To be determined
Reverse Transcription K1641 MAXIMA 1STR CDNA SYNTH KIT EA To be determined
Reverse Transcription K1642 MAXIMA 1STR CDNA SYNTH KIT EA To be determined
Reverse Transcription K1651 MAXIMA H MINUS FIRST STRAND CDNA SYNTHESIS KIT To be determined
Reverse Transcription K1652 MAXIMA H MINUS FIRST STRAND CDNA SYNTHESIS KIT To be determined
Reverse Transcription K1671 MAXIMA FIRST STRAND CDNA SYNTHESIS KIT WITH DSDNASE To be determined
Reverse Transcription K1672 MAXIMA FIRST STRAND CDNA SYNTHESIS KIT WITH DSDNASE To be determined
Reverse Transcription K1681 MAXIMA H MINUS FIRST STRAND C DNA SYNTHESIS KIT WITH DSDNASE To be determined
Reverse Transcription K1682 MAXIMA H MINUS FIRST STRAND C DNA SYNTHESIS KIT WITH DSDNASE To be determined
Reverse Transcription K1691 REVERTAID RT KIT EA To be determined
Reverse Transcription M1661 MAXIMA H MINUS MASTERMIX 50 RXN To be determined
Reverse Transcription M1662 MAXIMA H MINUS MASTERMIX 200 RXN To be determined
Reverse Transcription M1681 MAXIMA H(-) MASTERMIX W/ DNASE 50 RXN To be determined
Reverse Transcription M1682 MAXIMA H(-) MASTERMIX W/ DNASE 200 RXN To be determined
Reverse Transcription EP0441 REVERTAID RT EA To be determined
Reverse Transcription EP0442 REVERTAID RT EA To be determined
Reverse Transcription EP0451 REVERTAID H MINUS RT EA To be determined
Reverse Transcription EP0452 REVERTAID H MINUS RT EA To be determined
Reverse Transcription EP0741 MAXIMA REVERSE TRANSCRIPTASE EA To be determined
Reverse Transcription EP0742 MAXIMA REVERSE TRANSCRIPTASE EA To be determined
Reverse Transcription EP0743 MAXIMA REVERSE TRANSCRIPTASE EA To be determined
Reverse Transcription EP0751 MAXIMA H MINUS REVERSE TRANSCRIPTASE To be determined
Reverse Transcription EP0752 MAXIMA H MINUS REVERSE TRANSCRIPTASE To be determined
Reverse Transcription EP0753 MAXIMA H MINUS REVERSE TRANSCRIPTASE To be determined
Reverse Transcription K2561 Maxima H Minus Double-Stranded cDNA Synthesis Kit, 10 rxn To be determined
Reverse Transcription K2562 Maxima H Minus Double-Stranded cDNA Synthesis Kit, 50 rxn To be determined
Reverse Transcription K2563 Maxima H Minus Double-Stranded cDNA Synthesis Kit, 200 rxn To be determined
Reverse Transcription EN0771 dsDNase To be determined
Reverse Transcription 11750150 SuperScript IV CellsDirect cDNA Synthesis Kit To be determined
Reverse Transcription 11750350 SuperScript IV CellsDirect cDNA Synthesis Kit To 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.
 

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 .