S&S makes sure to run all operations and procedures according to well-known standards of quality, environmental protection and safety. This commitment is established by the periodic certification according to ISO 9001, ISO 14001 respectively.
S&S maintains the Certification of GMP compliance by Swissmedic which authorizes the manufacturing of Active Pharmaceutical Ingredients API. In terms of regulatory compliance, S&S is well aware of the European chemical legislation and fullfills all necessary requirements of REACH.
Regulation (EC) No. 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)
REACH is a task we take on in order to fulfil all the requirements to carry on our business and even strengthen it. As a producer outside of the EU we took the opportunity to establish an Only Representative of a non-Community Manufacturer according to REACH Regulation article 8.1.
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ExperChem fulfils all relevant obligations defined by REACH for the products manufactured by Schärer & Schläpfer AG.
The assignment of an OR enables us to continue and extend existing business relations with our customers situated within the EU. Therefore, our customers can be assured that we and our OR act according to the currently effective REACH regulation.
Most of our products are polymers, as defined by the REACH regulation, for which a registration is not foreseen. Hence, the corresponding (pre-)registration as well as in- or exclusion of any particular use (and corresponding exposure scenarios) are not necessary. Nevertheless, we gladly take note of all identified uses provided by you. We will then prove in what extend the adoption of this information into the safety data sheet would be expedient and beneficial.
The monomers and reactants of our polymers are, in contrast to the polymers themselves, preregistered in the EU in compliance with the requirements for re-imports. Turkey Red Oils (sulphated castor oil sodium salt, ECHA-Dossier:Castor oil, sulfated, sodium salt) and Aduxol RIC-0n (ethoxylated castor oil, ECHA-Dossier: Castor oil, ethoxylated)as far as the latter falling in the group of No-Longer Polymers (NLP) have been registered already by our OR ExperChem Ltd., who acts as registrant on our behalf. You will find the information about the corresponding registrations in the corresponding safety data sheets.
REGULATION (EC) No 1272/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 December 2008 on classification, labelling and packaging of substances and mixtures (CLP Regulation)
We are aware of our obligations resulting from the CLP regulation. The adaption of the classification and labelling requirements for our products according to the CLP regulation has already been implemented in due time. Our safety data sheets were updated accordingly.
The classification according to CLP may differ significantly from the previous EU-classification (Council Directive 67/548/EEC and Council directive 1999/45/EC). Please be reminded that this difference is not due to changes of the corresponding products or new hazard-related findings, but triggered by newly defined threshold values and concentration limits defined under CLP for the classification and labelling of substances and mixtures. Additionally, we would like to point out, that changes of the classification of substances or mixtures may also be necessary at later time points.
According to the CLP regulation all substances have to be notified to the CLP-register within four weeks after first receipt of the product in the EU. This requirement also applies to polymers, even though they do not require a REACH registration. This obligation cannot be fulfilled by Schärer & Schläpfer AG (producer outside the EU). In fact, this liability remains with the respective EU-customers acting as importer according to REACH. We can, however, offer our support with the conduction of this notification. In order to do so, merely minimal administrative provisions are necessary. With a signed agreement from you our REACH-OR ExperChem Ltd. is able to undertake the CLP notification on your behalf. Please do not hesitate to approach your contact person in our purchase department for this matter. The corresponding documents are ready for you.
SVHC Substances and Annex XIV of the REACH Regulation – List of Substances Subject to Authorisation
Substances of Very High Concern (SVHC) are subject to authorisation according to the REACH regulation. Once a substance is identified as SVHC, it is added to the so called “Candidate List”. This list is published on the ECHA website and is regularly updated by the agency.
Substances on the SVHC Candidate List are subject to extensive information obligations within the supply chain, but do not yet require authorisation. After inclusion of a substance in Annex XIV of the REACH regulation, however, an authorisation is mandatory.
Concerning our products the SVHC candidate substances nonylphenolethoxylate (4-Nonylphenol, branched and linear, ethoxylated)) and octylphenolethoxylate (4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated)) should be mentioned in this context. In regard to our product portfolio the products groups „Aduxol AH-0n“ and „Aduxol OP-0n“ are affected. The obligation to communicate the necessary information on SVHC along the supply chain, as stipulated by the ECHA, is fulfilled within the safety data sheets for the corresponding products.
Dr. Rudolf Stauber
Head of Development & Analytics