Quality

Schärer & Schläpfer AG 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. 

Schärer & Schläpfer AG maintains the Certification of GMP compliance by Swissmedic which authorizes the manufacturing of Active Pharmaceutical Ingredients API. In terms of regulatory compliance, Schärer & Schläpfer AG is well aware of the European chemical legislation and fullfills all necessary requirements of REACH.

In addition, our GMP compliance regularly undergoes independent third-party audits by Blue Inspection Body GmbH (Münster (Germany), blue-inspection.com). The audit reports are available from Diapharm GmbH (Münster (Germany), diapharm.com).

REACH (EU Regulation No. 1907/2006, dated 18 December 2006, regarding the Registration, Evaluation, Authorization and Restriction of Chemicals)

As a producer outside the EU, at an early stage we took the opportunity to appoint an only representative (pursuant to Art. 8.1 of REACH).

Chemservice carries out all obligations defined in REACH for Schärer & Schläpfer AG products. Our customers can therefore have complete confidence that we and our only representative are compliant with current REACH legislation.

Many of our products are polymers as defined in REACH. This class does not currently have to be registered under REACH. However, that will change when REACH undergoes revision (REACH Re-Opening). Implementation of the provisional timeline set out in mid-2023 will take a number of years:

• Q4/2023: Draft legislation
• 2026: Revision of REACH regulation, including Annexes
• 2027: New REACH regulation enters into force
• 2030: Notification of all polymers
• 2033: ECHA grouping criteria defined
• 2035: Registration of first polymer groups

Schärer & Schläpfer AG products that are not subject to any exemptions with regard to registration obligations have been registered by our REACH only representative. The information about those registrations can be found in the relevant safety data sheets.

In addition, we can provide support if an EU customer wishes to fulfill REACH obligations itself (as importer).

CLP Regulation (EU Regulation No. 1272/2008 dated 16 December 2008, regarding the classification, labeling and packaging of substances and mixtures)

• We are aware of our obligations arising from the CLP Regulation. The classification and labelling of our products under the current CLP Regulation is standard.
• The basis for classification of most of our products is the current version of the CESIO RECOMMENDATIONS for the harmonized classification and labeling of surfactants (the latest C&L recommendations).
• The classification of substances and mixtures may undergo changes in light of new findings, data or legislation.
• Under the CLP Regulation, registration in the CLP Register is mandatory (no volume threshold) for all substances, including polymers that do not yet have to be registered pursuant to REACH (no volume threshold). This obligation cannot be fulfilled by Schärer & Schläpfer AG (producer outside the EU), nor by our REACH only representative Chemservice GmbH. Instead, this obligation must be fulfilled by the EU customer. Nonetheless, we can provide you with support and relieve you of the expense by taking simple administrative measures.

(ECHA, via Poison Centre Notification Portal) and unique formula identifier (UFI) – Annex VIII of the CLP Regulation

As a producer outside the EU we are unable to perform this task ourselves, and our REACH only representative cannot perform this task either. This is because only representatives are not defined in the CLP Regulation (by contrast with REACH). Nevertheless, we can provide you with advice and assistance.

SVHC substances and Annex XIV of REACH (Authorization List)
For Substances of Very High Concern (SVHCs), there is a REACH authorization procedure. If a substance is identified as an SVHC, it is placed on the candidates list. This is published on the ECHA website and updated regularly. Substances on this list must fulfill comprehensive information requirements in the supply chain, but do not yet have to be registered. Registration is only required if the substance is moved from the candidates list to Annex XIV (the list of substances requiring authorization).

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.