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 areaSKUDescriptionUpdated products start from Lot Number*
Reverse Transcription12594025SUPERSCRIPT IV 1-STEP SYSTEM 25 RXNTo be determined
Reverse Transcription12594100SUPERSCRIPT IV 1-STEP SYSTEM 100 RXNSTo be determined
Reverse Transcription12595025SUPERSCRIPT IV 1-STEP SYSTEM 25 RXNSTo be determined
Reverse Transcription12595100SUPERSCRIPT IV 1-STEP SY DNASE 100 RXNSTo be determined
Reverse Transcription18090050SUPERSCRIPT IV 10,000 unitsTo be determined
Reverse Transcription18090200SUPERSCRIPT IV 4 x 10,000 unitsTo be determined
Reverse Transcription18091050SUPERSCRIPT IV 1ST STRND SYSTM 50 reactionsTo be determined
Reverse Transcription18091150SSIV SYSTEM WITH EZDNASE 50 RXNSTo be determined
Reverse Transcription18091200SUPERSCRIPT IV 1ST STRND SYSTM 200 reactionsTo be determined
Reverse Transcription18091300SSIV SYSTEM WITH EZDNASE 200 RXNSTo be determined
Reverse Transcription11756050SUPERSCRIPT IV VILO MASTERMIX 50 RXNSTo be determined
Reverse Transcription11756500SUPERSCRIPT IV VILO MASTERMIX 500 RXNSTo be determined
Reverse Transcription11766050SSIV VILO MASTERMIX W/ EZDNASE 50 RXNSTo be determined
Reverse Transcription11766500SSIV VILO MASTERMIX W/ EZDNASE 500 RXNSTo be determined
Reverse Transcription11766051ezDNase EnzymeTo be determined
Reverse TranscriptionAB1453AVERSO CDNA KIT EATo be determined
Reverse TranscriptionAB1453BVERSO CDNA KIT EATo be determined
Reverse TranscriptionAB1454LDBVERSO 1-STEP RT-PCR REDDYMIX KITTo be determined
Reverse TranscriptionK1612FIRST STRAND CDNA SYNTH KIT EATo be determined
Reverse TranscriptionK1621REVERTAID 1ST CDNA SYNTH KIT EATo be determined
Reverse TranscriptionK1622REVERTAID 1ST CDNA SYNTH KIT EATo be determined
Reverse TranscriptionK1631REVERTAID H MINUS 1ST CDNA KIT EATo be determined
Reverse TranscriptionK1632REVERTAID H MINUS 1ST CDNA KIT EATo be determined
Reverse TranscriptionK1641MAXIMA 1STR CDNA SYNTH KIT EATo be determined
Reverse TranscriptionK1642MAXIMA 1STR CDNA SYNTH KIT EATo be determined
Reverse TranscriptionK1651MAXIMA H MINUS FIRST STRAND CDNA SYNTHESIS KITTo be determined
Reverse TranscriptionK1652MAXIMA H MINUS FIRST STRAND CDNA SYNTHESIS KITTo be determined
Reverse TranscriptionK1671MAXIMA FIRST STRAND CDNA SYNTHESIS KIT WITH DSDNASETo be determined
Reverse TranscriptionK1672MAXIMA FIRST STRAND CDNA SYNTHESIS KIT WITH DSDNASETo be determined
Reverse TranscriptionK1681MAXIMA H MINUS FIRST STRAND C DNA SYNTHESIS KIT WITH DSDNASETo be determined
Reverse TranscriptionK1682MAXIMA H MINUS FIRST STRAND C DNA SYNTHESIS KIT WITH DSDNASETo be determined
Reverse TranscriptionK1691REVERTAID RT KIT EATo be determined
Reverse TranscriptionM1661MAXIMA H MINUS MASTERMIX 50 RXNTo be determined
Reverse TranscriptionM1662MAXIMA H MINUS MASTERMIX 200 RXNTo be determined
Reverse TranscriptionM1681MAXIMA H(-) MASTERMIX W/ DNASE 50 RXNTo be determined
Reverse TranscriptionM1682MAXIMA H(-) MASTERMIX W/ DNASE 200 RXNTo be determined
Reverse TranscriptionEP0441REVERTAID RT EATo be determined
Reverse TranscriptionEP0442REVERTAID RT EATo be determined
Reverse TranscriptionEP0451REVERTAID H MINUS RT EATo be determined
Reverse TranscriptionEP0452REVERTAID H MINUS RT EATo be determined
Reverse TranscriptionEP0741MAXIMA REVERSE TRANSCRIPTASE EATo be determined
Reverse TranscriptionEP0742MAXIMA REVERSE TRANSCRIPTASE EATo be determined
Reverse TranscriptionEP0743MAXIMA REVERSE TRANSCRIPTASE EATo be determined
Reverse TranscriptionEP0751MAXIMA H MINUS REVERSE TRANSCRIPTASETo be determined
Reverse TranscriptionEP0752MAXIMA H MINUS REVERSE TRANSCRIPTASETo be determined
Reverse TranscriptionEP0753MAXIMA H MINUS REVERSE TRANSCRIPTASETo be determined
Reverse TranscriptionK2561Maxima H Minus Double-Stranded cDNA Synthesis Kit, 10 rxnTo be determined
Reverse TranscriptionK2562Maxima H Minus Double-Stranded cDNA Synthesis Kit, 50 rxnTo be determined
Reverse TranscriptionK2563Maxima H Minus Double-Stranded cDNA Synthesis Kit, 200 rxnTo be determined
Reverse TranscriptionEN0771dsDNaseTo be determined
Reverse Transcription11750150SuperScript IV CellsDirect cDNA Synthesis KitTo be determined
Reverse Transcription11750350SuperScript IV CellsDirect cDNA Synthesis KitTo 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

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.