Quality & Compliance

Quality is the foundation of our company. setral® introduced a quality management system according to DIN EN ISO 9001 back in 1997. Many other measures in the area of quality followed. This page features the most significant measures undertaken.

For us, quality also means awareness of our role and responsibility towards society, the environment and, of course, our partners. setral® is committed to its stakeholders and keeps an eye on the scope of its actions. That is why compliance is an integral part of our quality philosophy.

 

 

Qualitätsmanagement nach DIN EN ISO 9001:2015

It is our goal to only develop, produce and deliver products that meet the requirements of the market.

We are extremely commited to not only use our state of the art research laboratories but also to reliably guarantee the high standard of quality of our products to our customers. As early as 1997, the executive board of setral® has introduced a quality management system in accordance with DIN EN ISO 9001 and made sure that all necessary resources and skills were available.

Since then, this quality management system has been continuously optimized and adapted to the requirements of a process-oriented system. Now we are certified according to the latest DIN EN ISO 9001:2015.

Environmental management according to DIN EN ISO 14001:2015

One of our founding principles was to make an active contribution to environmental protection right from the start.

Sustainable business is not just a requirement of reason, but our responsibility for the future. A foresighted, voluntary and systematic inclusion of all relevant environmental aspects in our corporate policy has not only an ideal value for us, but also a material value due to the conservation of limited resources.

We and our customers benefit from this profit. Our environmental management meets the current requirements of DIN EN ISO 14001: 2015 and is also continuously optimized to meet tomorrow's requirements today.

setral® is proud to be able to say: "Our investments stand for a sustainable future".

Certified hygiene standard for food lubricants: DIN EN ISO 21469

setral® is DIN EN ISO 21469 certified. This standard specifies hygiene requirements for the formulation, manufacture, use and handling of lubricants that can come unpredictably into contact with e.g. food during the production.

With the production of food, beverages, tobacco products, animal feed and pharmaceutical articles as well as their packaging, accidental contact between the product and the lubricant cannot always be completely ruled out. Wherever cross-contamination is theoretically possible, it is imperative to use a lubricant approved for this situation.

This certification issued by NSF or QMS International relates to the "Safety of machines Lubricants with incidental product contact - Hygiene requirements" and is the internationally recognized standard for the production of H1 lubricants. The standard DIN EN ISO 21469: 2006 describes the significant hazards and requires a basic strategy of the manufacturer of specialty lubricants for the selection of hygiene-related measures. A risk assessment serves as the basis for determining the required measures. Annual on-site audits ensure independent verification of the hygiene strategies and the implementation of the required measures in the Production of H1 lubricants.


H1 lubricants: NSF & InS

Since 1969 setral® has been developing, producing and selling specialty lubricants for a wide range of industrial applications worldwide. Today, we are certified according to ISO 9001, 14001 and most recently also according to ISO 21469. We are one of the world's leading manufacturers of H1-registered specialty lubricants. setral® has more than 100 H1 and H1 compliant lubricants in a wide variety of lubricant packages in its range and delivers them to renowned customers from the food, beverage and packaging industries worldwide. They particularly appreciate the competence and reliability in quality and delivery reliability of their lubricant partner. setral® actively supports and advises its partners from the food industry in the implementation of their HACCP strategy and, if necessary, also develops customized H1 lubricants.

Internationally, there is no uniform regulation. However, the H1 standard, in particular, has largely established itself as a globally recognized standard for lubricants. This was originally defined by the USDA (U.S. Department of Agriculture) in the U.S. in the 1960s. Institutions like the NSF or InS register lubricants according to this standard. H1 registered lubricants are to be used at CCPs (critical control points). As a CCP, the HACCP (hazard analysis and critical control points) considers the lubrication points that are above or to the side of the food line and lubrication points below the food line that are under pressure. In the meantime, many producers in the food industry and other relevant industries have defined all lubrication points as CCPs to prevent contamination of non-H1 lubricants with H1 lubricants.

Kosher and Halal certified lubricants

The setral® product range includes a range of food grade lubricants that are Kosher and Halal certified. Worldwide, the food laws of Jewish and Muslim populations are gaining attention in the food and beverage industry. Not only the food and beverages themselves are subject to strict rules, but also the production and the environment in which they are produced and stored. When choosing kosher food that complies with Jewish dietary law and halal food that complies with Islamic dietary law, care must be taken to select the right specialty lubricant. In order to actually produce compliant food, a simple H1 certification is usually not enough. To ensure appropriate conformity, kosher and halal certified H1 lubricants are used in production.

 

Blue Angel as an award for particularly environmentally conscious products

The Blue Angel is only awarded to products that are particularly environmentally friendly. setral® is proud to be able to use the Blue Angel on selected products. The fragility of the terrestrial and aquatic habitat presents the lubricant industry with the challenge of developing environmentally friendly, low-pollutant and biodegradable lubricants, so-called “environmentally acceptable lubricants” (EAL). A challenge that we are happy to accept

 

The setral® REACh-statement

For years we are actively campaigning for a responsible use of chemicals and environment, a safe manufacturing of products and a riskless application of these products by our customers.

EC regulation no. 1907/2006 – REACh deals with the Registration, Evaluation, Authorization of Chemicals. Since its coming into force on the 1st of June 2007 it centralizes and simplifies the pan-European chemical law. According to the REACh regulation all substances that are being produced or imported in amounts of more than 1 ton annually have to be registered. This is valid for the substances themselves as well as for substances in mixtures and substances that are being released by commodities.

setral®Chemie GmbH initiated the necessary steps to assure the availability of all setral® products in the future. This of course encloses pre-registration respectively registration of all raw materials that we buy or produce ourselves. Till the deadline on 12/01/2008 all raw materials (et al. thickener) that are being produced or possibly could be produced have been pre-registered. All products placed on the market by setral® are by definition “preparations” that do not have to be registered at the European Chemical Agency (ECHA) in Helsinki, Finland. In contrast substances that are being used for the production of some of our products (greases), are compulsory to registration.

Particularly we contacted our EU suppliers of whom we purchase chemical substances that we use during our manufacturing processes. Our processes are mainly widely-used operations that are being applied by numerous sectors in high tonnages. Behind this background many of our suppliers signalized that the pre-registration respectively registration of the relevant substances has been arranged respectively a later registration is going to be done.

Thus from today’s point of view we can guarantee the delivery of all setral® products in usual quality and quantity in the future.

In order to efficiently and coordinated fulfill our duties regarding REACh we joined forces with other European grease manufacturers in the ERGTC (European REACh
(European REACh Grease Thickeners Consortium).

A further part of REACh is the so called list of candidates (SVHC = Substances of Very High Concern). This list contains substances that are of special interest on the part of ECHA. The list of SVHC-substances currently enfolds 181 substances (updated on 01/03/2018) and is published on the homepage of the ECHA under https://echa.europa.eu/candidate-list-table. We have registered at the ECHA all our grease thickeners requiring mandatory registration.

According to article 33 of the REACh regulation we are subject to reporting requirement to our customers in case a worrisome substance (SVHC) is contained in our delivered product with a mass concentration of more than 0.1 percent. It is our own concern that behind the background of a high delivery and product safety we take this reporting requirement very seriously. We comply with the statutory provisions according to article 33 of the REACh regulation by following procedure:

Our EU-suppliers are committed to promptly inform us without the necessity of a further request in case one of their delivered products contains a SVHC of more than 0.1 mass percentages. As soon as we have that information we are directly going to forward it to you according to article 33 of the REACh regulation.

We make separate agreements with our non-EU-suppliers since they are not automatically liable to the REACh reporting requirement. Thus, we have written commitments with them that they have to instantaneously inform us if one of their delivered products has SVHC-concentrations above 0.1 mass percentages.

Should you still have further questions on the implementation of the REACh regulations in our company, please do not hesitate to contact us.


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