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Product safety.

REACh Regulation

Information on SVHC

Food contact

Eco-label

Product safety.

In view of the complex and constantly evolving national and international Chemicals Legislation as well as the diverse application possibilities of our additives, numerous regulatory challenges arise. Thanks to our dedicated Product Safety Department we can ensure that all requirements are carefully checked to meet the highest standards. Of course, we will be happy to answer any questions you may have.

REACh

 

The REACh Regulation (EC) No. 1907/2006 is the European Chemicals Regulation on the Registration, Evaluation, Authorisation and Restriction of Chemicals (Registration, Evaluation, Authorisation and Restriction of  Chemicals), which came into force in 2007. According to this EU regulation, substances that are imported or manufactured in quantities of > 1t per year must be registered. The last transitional period for registration ends on 31 May 2018. However, certain groups of substances, such as polymers, are exempt from the registration obligation.

Due to the high costs associated with a REACh registration, it is to be expected that many companies will no longer produce certain substances after the end of the transition period on 31 May 2018. We are therefore in constant contact with our producers and suppliers to check the registration status of our raw materials. At present, we do not expect our product portfolio to change fundamentally beyond May 2018 due to the effects of REACh. Should it nevertheless be necessary to adjust our product portfolio, we will inform all affected customers in order to work out solutions together in a timely manner. Solutions that work.

”We, Schäfer Additivsysteme GmbH, are facing the challenges associated with REACh and have committed ourselves to implementing this regulation accordingly. We assure you that all our products and their ingredients are pre-registered, registered or exempted from the REACh registration requirement and are marketable in the EU.

Safety Data Sheets (SDS / SDB)

 

Schäfer Additivsysteme prepares its safety data sheets in accordance with the regulations and specifications of the REACh Regulation (EC) No. 1907/2006, Art. 31 in conjunction with Annex II. The safety data sheets are regularly checked and updated. The REACh regulation states that for products that do not contain substances classified as hazardous above the consideration limits, the preparation of a safety data sheet is generally not required.

”However, we, Schäfer Additivsysteme GmbH, go beyond the requirements of the legislator here and are happy to provide our customers with a safety data sheet for each of our products.

Classification and labelling

 

The classification and labelling of our products is carried out in accordance with the CLP Regulation (EC) No. 1272/2008. The replacement of the old Directives 67/548/EEC and 1999/45/EC by the new CLP Regulation resulted in many changes. New hazard classes and modified classification criteria led to a tightening of the classification for many substances and mixtures in connection with the changeover from the old directives to the new CLP Regulation. New findings from the studies carried out as part of the REACh registrations have already led to a further tightening of the classification of numerous raw materials in the past.

”We, Schäfer Additivsysteme GmbH, strive for the best possible classification of our products for the benefit of our customers. Within the scope of our product development, we therefore also pay special attention to the classification of raw materials when selecting them.

Chemicals inventories (country listing)

 

Many countries have introduced chemical inventories that list all chemicals manufactured in or imported into a country. In countries where such an inventory exists, a substance can only be manufactured, imported or marketed if it is listed in the corresponding inventory. The listing status is listed in our "Regulatory Information Sheets", which we will be happy to send you on request.

We check the listing status of our products in the following inventories as standard:

wdt_ID Country Standard
1 USA TSCA (Chemical Substance Inventory)
2 Canada DSL / NDSL (Canadian (Non-)Domestic Substances List)
3 Australia AICS (Australian Inventory of Chemical Substances)
4 New Zealand NZIoC (New Zealand Inventory of Chemicals)
5 China IECSC (Inventory of Existing Chemical Substances in China)
6 Japan ENCS / MITI (Japanese Existing and New Chemical Substances)
7 Japan ISHL (Japanese Industrial Safety and Health Law)
8 South Korea ECL (Korean Existing Chemical List)
9 Philippines PICCS (Philippines Inventory of Chemicals and Chemical Substances)
10 Taiwan TCSI (Taiwan Chemical Substances Inventory)

SVHC - Statement

 

SVHC ("Substances of Very High Concerns") are substances of very high concern published by the European Chemicals Agency ECHA in the so-called "Candidate List". The Candidate List is the list of substances considered for inclusion in Annex XIV. With the inclusion in Annex XIV, there is an authorisation obligation for the substance. Although the SVHC status alone does not result in an authorisation obligation, it does result in far-reaching information obligations in the supply chain.

If one of our products contains a SVHC, a PBT substance or a vPvB substance above the consideration threshold of 0.1%, Schäfer Additivsysteme will fulfil its communication obligation according to Article 33 of the REACh Regulation by passing on this information in the corresponding safety data sheet. Corresponding information can be found in sections 2.3, 12.6 and 15.1 of the safety data sheet. However, as part of our quality control, we do not test our products for traces (< 0.1%) of all the substances of concern mentioned above. We can therefore not formally guarantee their complete absence.

”We, Schäfer Additivsysteme GmbH, assure our customers that no substances on the Candidate List or Annex XIV are used in our formulations. It is our claim to avoid such substances of concern in the interest of our customers and to replace them with safer substances. It is part of our development to regularly follow the activities of the ECHA and the member states with regard to the evaluation of our products and raw materials in order to be able to evaluate possible alternatives at an early stage.

Food contact

 

Food contact materials (FCM) are all materials and commodities with which food comes into contact during its production (harvesting, transport, preparation, storage), its trade (packaging) and its consumption (final preparation, preparation, consumption). A variety of different materials such as plastics, rubber, paper or metal can be used.

Through contact with food, components of these materials can be transferred to the food, for example through migration. The aim of the general legislation is therefore to exclude, as far as possible, a health hazard due to such migration. While in the USA this is centrally regulated by the FDA in chapter 21 CFR, in Europe there is a complex mixture of harmonised EU regulations, national regulations and recommendations.

General regulationsPlasticsLubricants

General rules and regulations

European Union (EU)

At European level, the general requirements for the safety of food contact materials and articles are laid down in the so-called Framework Regulation (EC) No. 1935/2004. The manufacturer of the material or article is responsible for the conformity of the final product with the provisions in Article 3.

According to Article 3, food contact materials and articles shall not, under normal or foreseeable conditions of use, transfer substances to food that are suitable,

  1. endanger human health,
  2. bring about an unacceptable change in the composition of the food; or
  3. cause an impairment of the smell, taste, texture or appearance of the food (so-called organoleptic properties).

In addition to the overarching EU Framework Regulation, manufacturers of consumer goods must comply with many other regulations, such as the requirements for good manufacturing practice (GMP) (Regulation (EC) No. 2023/2006) or individual material-specific measures, such as Regulation (EU) No. 10/2011 for plastics.

 

Germany

The European requirements have been largely integrated into national laws. The German counterpart to the EU Framework Regulation is the "Lebensmittel-, Bedarfsgegenstände- und Futtermittelgesetzbuch (LFGB)". This replaced the old Foodstuffs and Consumer Goods Act (LMBG) in 2005 and is the umbrella law for German food law. Article 3 of the EU Framework Regulation was incorporated here, for example, in §31, para. 1.

 

BfR recommendations

The Federal Institute for Risk Assessment (BfR) develops recommendations within the framework of the German "Food, Commodities and Feed Code (LFGB)", which can be found in the database "BfR Recommendations on Food Contact Materials" (formerly "Plastics Recommendations").

The BfR recommendations on food contact materials do not constitute legal standards. However, they are based on the European legal situation and its implementation in national law and reflect the current state of science and technology. They are therefore nevertheless an important and accepted guide to deriving whether a food contact article meets the legal requirements of the EU Framework Regulation (EC) No. 1935/2004 or the LFGB. The BfR recommendations are particularly important for food contact materials that have not been specifically regulated at EU level to date, such as silicones, paper and rubber.

 

USA / FDA

The aim of the US Food and Drug Administration (FDA) is to ensure safe food. Title 21 of the Code of Federal Regulation (CFR) lists all substances permitted for contact with foodstuffs as determined by the US authorities. These positive lists contain substances that are suitable for contact with food. In contrast to the EU, the positive lists and the exact requirements therein are very material-specific.

It is assumed that in principle all components of a material can migrate into food. Therefore, all materials and ingredients are referred to as "indirect food additives".

Title 21 is divided into chapters (Parts). Relevant for food contact materials are Parts 170-190, which are further subdivided. In these paragraphs, the requirements for the respective material for food contact are regulated. These requirements refer on the one hand to the ingredients in the material and on the other hand also to further, additional requirements.

In addition, substances from the so-called GRAS lists ("Generally Recognized As Safe"; Parts 182-184) or so-called "Prior-Sanctioned Food Ingredients" (Part 181) can be used as additives for all food contact materials at any time.

Plastics

EU regulations

Within the framework Regulation (EC) No 1935/2004 there are some specific measures on certain materials. One of these individual measures is Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food. This regulation, also known as the PIM (Plastics Implementation Measure), replaces the former "Plastics Directive" (2002/72/EC). In the meantime, a number of corrections and amendments to this regulation exist.

When plastics come into contact with food, components of the plastics can migrate to the food. The aim is to exclude, as far as possible, a health hazard due to such migration.

For this purpose, Regulation (EU) No 10/2011 establishes a positive list (Union list) of monomers and additives that may be used in the manufacture of plastic food contact materials and articles. Components of the Union list do not include polymerisation aids (catalysts, accelerators, initiators, etc.) or colourants. For "polymer production aids" (PPA) the Union list is not comprehensive. Substances not covered by the Union list are subject to national legislation and recommendations (e.g. the BfR recommendations).

Before inclusion in the Union list, substances have to be tested for their possible transfers to food and their toxicological properties. Based on these results, upper limits of permitted migration into food are set for some substances, so-called "specific migration limits (SML)". For all substances for which no SML was set, a "general SML" of 60 mg/kg applied for a long time. However, this was abolished at the end of 2016 with the amending Regulation (EU) 2016/1416. For substances for which such a specific migration limit (SML) cannot be verified, there are also quantitative restrictions (maximum concentrations) in the material (QM) instead. This limits or excludes a transfer to food as a precautionary measure. An overall limit is set for the sum of all substances migrated into the food, the "overall migration limit (OML)". This OML is defined as 10 mg per dm2 of the food contact surface of the material, or 60 mg per kg of food.

Substances that have not been evaluated must not be detectable in food. The generally accepted and practicable detection limit of 10 ppb (0.01 mg/kg) is considered "undetectable" today. This limit is also set in the amending Regulation (EU) 2016/1416 in Article 11, paragraph 4.

Polymers and substances with a molecular mass greater than 1,000 Daltons generally have little to no migration potential. Furthermore, these substances are not absorbed from the gastrointestinal tract and therefore pose virtually no toxicological risk in the eyes of the European Food Safety Authority (EFSA). Consequently, polymers and substances > 1,000 Daltons also have no significance in the sense of EU regulations and national laws and recommendations.

 

National regulations

The German Consumer Goods Ordinance (BedGgstV) can be regarded as the national counterpart to EU Regulation No. 10/2011. The BedGgstV lists the substances that may not be used in the commercial manufacture or treatment of certain consumer goods (§3, Annex 1) or may only be present in food consumer goods up to a certain maximum quantity (§6, Annex 5). The transfer of substances from plastics into food is also regulated in the BedGgstV (§6).

 

BfR recommendations

The focus of the recommendations was originally in the area of plastics for food contact. However, harmonised legislation now exists for plastics at European level, such as Regulation (EU) No 10/2011 in particular, which largely regulates this area. Many of the substances originally included in the Plastics Recommendations were gradually incorporated into the Consumer Goods Ordinance or the Union List and subsequently deleted from the BfR Recommendations.

For this reason, the BfR recommendations in the area of plastics now only take into account those substances that are not or not exhaustively covered by the Union list of EU Regulation No. 10/2011. These include the "aids to polymerisation", which include the components of the catalytic system (catalysts and initiators), and the "polymer production aids" (PPA), which include, for example, emulsifiers that are required in the manufacturing process.

 

FDA

In Title 21 of the Code of Federal Regulation (CFR), Parts 177 and 178 are particularly relevant for plastics. Part 177 - "Indirect Food Additives: Polymers" lists the different types of polymers in individual paragraphs. The requirements for polyolefins, for example, are in §177.1520 and those for polyurethanes in §177.1680. In "Part 178 - Indirect Food Additives: Adjuvants, Productions Aids, and Sanitizers", various additives, adjuvants and auxiliary substances are described in corresponding paragraphs. For example, the relevant paragraph for antioxidants is §178.2010 and colourants are regulated in §178.3297. In addition, the substances listed in the GRAS paragraphs (Parts 182-184) and the "Prior-Sanctioned Food Ingredients" (Part 181) can of course be used at any time.

If an additive is not listed in the paragraph intended for the intended use, it is still possible to use it based on the "no-migration" principle. If FDA-recognised migration studies show that the substance concentration in the food is below 50 ppb in the desired application, this principle can be applied on the company's own responsibility. For packaging materials with a high market share and thus a high consumer exposure, a limit value of 10 ppb is recommended by the FDA ("consumption factor").

 

Why we cannot guarantee final compliance when using our additives in food contact materials...

The migration potential of a particular substance can depend on many different factors, including:

  • the type of plastic / polymer,
  • the properties of the food (e.g. dry, watery, sour, fatty),
  • Interactions with other plastic additives,
  • the ratio between packaging surface and volume.

Therefore, the final compliance with the legal requirements has to be done by the manufacturer of the final food contact material / article of daily use, taking into account the respective use and conditions of use. For this reason, we recommend carrying out migration tests on the final product to check and confirm compliance. Testing can only be dispensed with if a limit crossing can be excluded from the ratio of packaging to product mass when assuming complete migration of the migrant (worst case). If you require more detailed information on our products in this regard, please do not hesitate to contact us. We will be happy to help you.

 

What we do for you...

We check as standard whether our products or their ingredients are included in the Union list of Regulation (EU) No. 10/2011. If our products contain polymers or substances with a molecular weight of > 1,000 Dalton only, we will be happy to advise you on request. Furthermore, we check the FDA status of our products. You can find the relevant information in our "Regulatory Information Sheets", which we will be happy to send you on request.

At your request, we will also be happy to check the conformity of our products with other national or industry-specific regulations. We are also happy to advise you on the selection of products suitable for food contact. Solutions that work.

Lubricants

Lubricants can be used, among other things, as lubricants or as release agents in various components or machines (e.g. conveyor belts, seals, closures) which are used in locations where the lubricated component may come into contact with food. Since occasional, unintentional contact between lubricant and food cannot be completely ruled out, certain requirements must be observed and fulfilled.

For lubricants, the general rules and regulations apply in the EU and at national level, such as the EU Framework Regulation No. 1935/2004 or the LFGB (§31).

However, there are no specific EU regulations for food-grade lubricants - unlike plastics - and no specific national regulations either. For this reason, it is common to refer to the widely accepted US standards. In no other country are the legal regulations for the use of lubricants and lubricant additives as strict as in the USA.

 

FDA

In Title 21 of the Code of Federal Regulation (CFR), the FDA specifies which ingredients may be used for food lubricants. 21 CFR §178.3570 (Lubricants with incidental food contact) is particularly relevant in this regard. Additives for lubricants in contact with food must meet the requirements of this paragraph. In addition, as with plastics, the substances listed in the GRAS paragraphs (Part 182-184) can of course be used.

 

NSF certification according to H1 / HX-1

Until 1998, the United States Department of Agriculture (USDA) was responsible for the approval of food-grade lubricants. Since 1999, "NSF International" (National Sanitary Foundation) and "InS Services Ltd" have taken over this task.

A special lubricant for the food sector can only be approved if the requirements of the FDA are met. Depending on the requirements and specifications, the lubricants are divided into different classes. H1 lubricants ("Lubricants - General incidental contact") are of particular importance for the food sector.

The highest demands are placed on H1 lubricants. Only lubricants certified with H1 may be used at all points in the food, pharmaceutical and animal feed industries where incidental, technically unavoidable contact between the lubricant and the product may occur. The ingredients in H1 lubricants must be certified with HX-1 ("Ingredients for use in H1 lubricants - incidental contact"). Prerequisite for HX-1 certification is a listing in 21 CFR §178.3570 or a GRAS notification (Part 182 and 184). Otherwise, a time-consuming notification process is required.

We are pleased to announce that we have launched our product LUBIO® EP 3 successfully certified according to the standards of the NSF category HX-1. For further information, please refer to the NSF White Book™ or the Regulatory Information Sheet. It is our goal to continue to develop further LUBIO®-products to be certified. We are happy to answer any questions you may have.

We check the FDA status of our products and their ingredients as standard. You can find the relevant information in our "Regulatory Information Sheets", which we will be happy to send you on request.

On request, we are also happy to have other products certified by "NSF International" or by "InS Services Ltd." e.g. according to HX-1 - if this is possible. We are happy to support you!

At your request, we will also be happy to check the conformity of our products with other national or industry-specific regulations if this should be necessary for your applications of our products. We are also happy to advise you on the selection of products suitable for food contact - Solutions that work.

Eco-label

 

In many lubricant applications, substance discharges into the environment are unavoidable or at least cannot be completely ruled out. This applies in particular to saw chain oils and loss lubricants, but also to hydraulic oils, cooling lubricants and many other applications. Particularly in environmentally sensitive areas, lubricants - and their additives - should therefore have a high level of environmental compatibility.

In order to offer the user of lubricants the possibility of selecting lubricants that are as environmentally compatible and biodegradable as possible, eco-labels have been introduced at national and EU level. In Germany, this is the "Blue Angel" and at EU level the EU Ecolabel, which is often also referred to as Euroflower, Euro-Margerite or EU-Margerite.

When awarding these eco-labels, the focus is on the evaluation of ecotoxicity, biodegradability and sustainability. These eco-labels offer the supplier of lubricants the opportunity to demonstrate his environmental competence for all to see and thus also the opportunity to sustainably increase the market opportunities of his corresponding products. This is another reason why the number of eco-labelled products in the lubricant industry is steadily increasing.

 

LuSC list ("EU Ecolabel")

The Lubricant Substance Classification List (LuSC list) is a list of substances and products (additives) that fulfil the relevant criteria of the EU Ecolabel for lubricants. These criteria were revised with the EU Commission Decision 2018/1702/EU of 08 November 2018. The testing and assessment of the products is based on their biodegradability, aquatic toxicity and renewability by a competent body. The release of the product is granted by a Letter of Compliance (LoC). We will be happy to send you this on request. The application for the EU Ecolabel as well as the associated decision-making process of the competent bodies will be much easier and faster if you use additives in your lubricant formulations that are listed on the LuSC list.

We, Schäfer Additivsysteme GmbH, would like to make it easier for our customers to apply for the EU Ecolabel. On request, we are happy to have products included in the LuSC list at the customer's request - if this is possible. We will be happy to support you!

We have already had some of our products in the areas of ageing protection (AS), antioxidants (AO), wear protection (AW), high pressure (EP) and corrosion protection (CI) evaluated by the responsible Dutch body SMK and included in the LuSC list. We are striving to expand this product selection in the future. Detailed information on the listed products can be found in our Ecolabel flyer take. If you have any questions, please do not hesitate to contact us.

 

RAL-UZ 178 ("The Blue Angel")

In Germany, the counterpart to the LuSC list at EU level is Annex 1 of the award criteria RAL-UZ 178 for "Biodegradable lubricants and hydraulic fluids".

This list is intended to make it much easier for manufacturers of lubricants and hydraulic fluids to apply for the "Blue Angel" for their product, as no further data need to be submitted for products listed in this Annex 1. The testing and assessment of the products is based on comparable principles to the EU Ecolabel and is carried out by RAL gGmbH. The approval of the product is confirmed by a "Declaration". We will be happy to send you this on request.

We, Schäfer Additivsysteme GmbH, would also like to make it easier for our customers to apply for the "Blue Angel" for lubricants and hydraulic fluids. Here, too, we are happy to have products included in Annex 1 of RAL-UZ 178 at the request of the customer - if this is possible. We will be happy to support you!