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