Adhesion promoters
An adhesion promoter is a substance which is applied to a substrate to improve the adhesion of a product to the substrate. The adhesion is created by the formation of strong bonds (including both covalent and non-covalent bonds) between the adhesion promoter and the surfaces of the products to be bound. In addition, some adhesion promoters in a first step chemically react to generate the adhesion properties. The substances thus formed during the use of an adhesion promoter are exempted from the registration provisions.
While the adhesion promoter itself is subject to registration, if it meets the necessary requirements, any substance generated as a result of chemical reaction when the adhesion promoter functions as intended, is exempted from registration, provided it is not itself manufactured, imported or placed on the market.
Example:
Silanes are applied to a substrate and hydrolyse into silanols in contact with moisture. The substance thus obtained acts as adhesion promoter in a second step.
Agglomerating agents
An agglomerating agent is a substance that binds solid particles together to form an agglomerate. The agglomeration process can involve chemical reactions between the agglomeration agent and the solid particles to be agglomerated.
While the agglomerating agent itself is subject to registration, if it meets the necessary requirements, any substance generated as a result of chemical reaction when the agglomerating agent functions as intended, is exempted from registration, provided it is not itself manufactured, imported or placed on the market.
Antifoamer or defoamer
An antifoamer or defoamer is an additive which is used to prevent or reduce foam formation. They work by reducing the surface tension of the liquid to the extent that the foam bubbles collapse and thereby destroy the foam which is already formed.
While the antifoamer or defoamer itself is subject to registration, if it meets the necessary requirements, any substance generated as a result of chemical reaction when the antifoamer functions as intended, is exempted from registration, provided it is not itself manufactured, imported or placed on the market.
Antioxidants
An antioxidant is a substance capable of slowing down or preventing the unwanted modification of other molecules (substances) caused by oxidation. Antioxidants inhibit oxidation reactions by being oxidized themselves or by removing free radicals. As a result, antioxidants are often reducing agents. While the antioxidant itself is subject to registration, if it meets the necessary requirements, any substance generated as a result of chemical reaction when the antioxidant functions as intended, is exempted from registration, provided it is not itself manufactured, imported or placed on the market.
Example:
Phenols used as antioxidants, for example 2,6-bis(tert-butyl)-4-methyl-phenol (EC No: 204-881-4; CAS No: 128-37-0). This substance will react rapidly with any adventitious radicals to form very stable phenoxy radicals which eventually become quinone type substances. Neither the radicals nor the resultants quinone type substances are subject to registration.
The phenoxy radicals generated are very stable due to their ability to build numerous mesomeric forms and are not subject to registration.
The end-products of the oxidation reaction are also not subject to registration.
Another example of this could be the production of the reaction product of the antioxidant tert-butyl-4-methoxyphenol (EC No: 246-563-8; CAS No: 25013-16-5), used to protect fatty acids from oxidation (with oxygen from air).
Binder
A binder is a substance used to bind different aggregates and other particles together and thereby adding strength to material. The reaction taking place can be either chemical or physical.
While the binder itself is subject to registration, if it meets the necessary requirements, any substance generated as a result of chemical reaction when the binder functions as intended, is exempted from registration, provided it is not itself manufactured, imported or placed on the market.
Carrier
A carrier is used to facilitate the transport of another product especially in a technical process. Typical examples are: Dyes can be chemically bonded to an inorganic support to facilitate the delivery of colour to paper in ink jet printing;
Catalysts can be chemically bound to the support material upon which they are held.
While the carrier itself is subject to registration, if it meets the necessary requirements, any substance generated as a result of chemical reaction when the carrier functions as intended, is exempted from registration, provided it is not itself manufactured, imported or placed on the market.
Chelating agents
The function of chelating agents, also called ligands, chelants, chelators or sequestering agents is to form a complex.
While the chelating agent itself is subject to registration, if it meets the necessary requirements, any substance generated as a result of chemical reaction when the chelating agents functions as intended, is exempted from registration, provided it is not itself manufactured, imported or placed on the market.
It has to be clarified that complexes consisting of chelated ions must be registered if they are themselves manufactured, imported or placed on the market.
Examples:
The chelating agent dimethylglyoxime is used as a detecting agent in laboratories for detecting nickel via its ability to bind nickel ions into complex compounds. The manufacture and import of dimethylglyoxime is subject to registration. However, when this chelating agent is used to complex nickel ions in industrial processes, the resulting nickeldimethylglyoxime complex does not need to be registered, unless this complex is manufactured or imported deliberately or placed on the market itself (e.g. by a formulator or importer).
Ethylenediaminetetraacetic acid (EDTA) is widely used to chelate metal ions in industrial processes. For example, in the textile industry, it prevents metals ions from modifying the colours for dyed products. It is also used in the production of chlorine- free paper where it chelates Mn2+ ions thus preventing the catalytic decomposition of the bleaching agent, hydrogen peroxide. While the general registration provisions apply to the manufacture or import of EDTA, the substances generated when EDTA functions as intended, are not subject to registration provided they are not themselves manufactured, imported or placed on the market.
Coagulants and flocculants
A coagulant is a chemical substance used to contribute to the molecular aggregation of substances present in a solution into particles.
A flocculant is a chemical substance used to promote the aggregation of suspended particles present in a liquid into a macroscopic mass called floc.
Coagulation and flocculation are two techniques commonly combined and are used for instance to remove dissolved organic matter and particles in suspension from water.
While the coagulant or flocculant itself is subject to registration, if it meets the necessary requirements, any substance generated as a result of chemical reaction when the coagulant or flocculant functions as intended, is exempted from registration, provided it is not itself manufactured, imported or placed on the market.
De-emulsifiers
A de-emulsifier is a substance used to facilitate the separation of two (or more) immiscible liquid phases present as an emulsion. A general mechanism of action for the de-emulsification is based on the interaction between the de-emulsifier and the substance causing the emulsion, and results in the destabilisation of this emulsion. The interaction between the de-emulsifier and the emulsifier may for instance consist of a chemical reaction between the two substances. While the de-emulsifier itself is subject to registration, if it meets the necessary requirements, any substance generated as a result of chemical reaction when the de- emulsifier functions as intended, is exempted from registration, provided it is not itself manufactured, imported or placed on the market.
Desiccant
A desiccant is a hygroscopic substance that functions as a drying agent, i.e. it withdraws moisture from other materials. It can retain water through capillarity or adsorption or by reacting chemically. Desiccants are used to dry solvents, gases and solids and lose their function as their water retention increases. Silica gel and molecular sieves are examples of commonly used desiccants. While the desiccant itself is subject to registration, if it meets the necessary requirements, any substance generated as a result of chemical reaction when the desiccant functions as intended, is exempted from registration, provided it is not itself manufactured, imported or placed on the market.
Example:
Calcium hydride (CaH2) is commonly used as desiccant. The mode of action of this drying agent is based on the chemical reaction taking place between calcium hydride and water, which results in the formation of calcium hydroxide (Ca(OH)2). While the registration provisions apply to the manufacture or import of calcium hydride, the calcium hydroxide formed as a result of its use as desiccant is exempted from registration as such.
Dewatering agent
Dewatering agent is a very general term for substances added during chemical treatment to improve the efficiency of water removal, e.g. clarifiers, flocculants, surfactants, etc. While the dewatering agent itself is subject to registration, if it meets the necessary requirements, any substance generated as a result of chemical reaction when the dewatering agent functions as intended, is exempted from registration, provided it is not itself manufactured, imported or placed on the market.
Dispersant
A dispersant is a substance that can promote the formation of a dispersion or stabilize the dispersion. The term dispersion is applied to a system of several phases in which one is continuous and at least one other is finely distributed. If two or more phases that are insoluble or only slightly soluble are finely distributed in one another, the term disperse system or, more simply, dispersion is used.
A dispersant generally does not change the solubility of the substance to be dispersed, but is often used to disperse sparingly soluble solids in water and keep them finely dispersed. Dispersants can be used to prevent a solution from turning into a colloidal dispersion.
[Strictly speaking one would consider this a suspending agent as a solid is finely dispersed in a liquid (emulsion)
Dispersants are generally polyelectrolytes that are readily soluble in water, e.g. alkali- metal polycarbonates, polysulfonates, or polyphosphates, usually sodium salts. Ligninsulfonates and condensation products of aromatic sulfonic acid with formaldehyde are also widely used.
Dispersants are used in the following fields, e.g.: production of polymer dispersions, adhesive dispersions, dispersion of dyes (textile industry), pigment dispersion (industrial paints, printing inks), cosmetic, pharmaceutical and photographic industry, detergents, cleaning and polishing products.
While the dispersant itself is subject to registration, if it meets the necessary requirements, any substance generated as a result of chemical reaction when the dispersant functions as intended, is exempted from registration, provided it is not itself manufactured, imported or placed on the market.
Filler
A filler is usually added to materials, such as polymers, to lower the consumption of more expensive binders or to improve the properties of the material, e.g. better mechanic properties (rubber used for tyres), to improve viscosity of resins (epoxy resins), or to control cost and/or viscosity or increase its strength (polymers), or tenacity and volume (dry wall).
Common fillers are:
- carbon black or 'soot' used in rubber tyres
- microspheres used in epoxy resins
- glass fibres used in polymers
- minerals, e.g. kaolin, limestone, gypsum used in paper
While the filler itself is subject to registration, if it meets the necessary requirements, any substance generated as a result of chemical reaction when the filler functions as intended, is exempted from registration, provided it is not itself manufactured, imported or placed on the market.
Fire retardants
A fire retardant is a substance used to protect a combustible material, for instance certain plastics or wood, against fire. The mechanism of action generally involves chemical reactions with the fire retardants under the conditions of a fire. While the fire retardant itself is subject to registration, if it meets the necessary requirements, when heated under fire conditions they release substances that quench the flame and thus prevent the fire from taking hold. The substances formed in such reactions do not need to be registered, provided it is not itself manufactured, imported or placed on the market.
Flavouring agent
A flavouring agent can be understood as a substance that gives another substance flavour.
While the flavouring agent itself is subject to registration5, if it meets the necessary requirements, any substance generated as a result of chemical reaction when the flavouring agent functions as intended, is exempted from registration, provided it is not itself manufactured, imported or placed on the market.
Examples:
Denatonium benzoate, is a flavouring agent that imparts a bitter taste. It is commonly added to products to deter human consumption.
Cigarettes contain, besides tobacco leaves, flavouring agents that give cigarettes particular aromas.
Flow modifier
A flow modifier is a substance added to a material (mainly liquids but also soft solids or solids under conditions in which they flow) in order to alter its flow characteristics. One example of the use of a flow modifier is in surface coatings in order to avoid surface defects such as craters, pinholes and orange peel when the coating is applied to a surface.
While the flow modifier itself is subject to registration, if it meets the necessary requirements, any substance generated as a result of chemical reaction when the flow modifier functions as intended, is exempted from registration, provided it is not itself manufactured, imported or placed on the market.
Lubricants
A lubricant is a substance applied between two moving surfaces to reduce the friction and wear between them. A lubricant provides a protective thin film which allows two surfaces to be separated while performing certain functionality by reducing the friction between them, improving efficiency and reducing wear. They may also have the function of dissolving or transporting foreign particles and of distributing heat. An example of one of the largest applications for lubricants in form of motor oil is to protect the internal combustion engines in motor vehicles and powered equipment. Lubricants, such as 2- cycle oil, are also added to some fuels.
5 Note: Substances used as flavouring in foodstuffs within the scope of Directive 88/388/EEC are exempted from registration (Article 2(5)(b) ii of REACH).
While the components of the lubricant itself (e.g. 2-cycle oil) are subject to registration, if they meet the necessary requirements, any substance generated as a result of chemical reaction when the lubricant functions as intended, is exempted from registration, provided it is not itself manufactured, imported or placed on the market.
Example:
Zinc dithiophosphates (ZDDPs) are substances commonly used in the formulation of lubricating oils for engines. Their mode of action includes the formation of a boundary layer to the surface to be lubricated and is known to require the chemical reaction of the ZDDPs. While the registration provisions apply to the manufacture or import of ZDDPs, the substances formed upon their use as lubricant and which contribute to the lubrication process are exempted from registration as such.
pH Neutralisers
A pH neutraliser is a substance used to adjust the pH-value of a solution, generally an aqueous solution, to the intended level. pH neutralisers are for instance used to balance the pH of drinking water or to discharge water from industrial processes. A pH neutraliser is not necessarily meant to be used to achieve pH neutrality but may in principle be used to achieve any pH value.
The neutralisation mechanism is based on acido-basic reaction between the pH neutraliser and the liquid to be treated. The reaction products from the pH neutraliser are exempted from the registration provisions. This does not apply to the deliberate formation of salts from acids or bases.
While the pH neutraliser is subject to registration, if it meets the necessary requirements, any substance generated as a result of the chemical reaction when the pH neutraliser functions as intended, is exempted from registration, provided it is not itself manufactured, imported or placed on the market. Additional background information on the conditions under which these substances may qualify for such an exemption is provided in Attachment 1.
Plasticiser
A plasticiser is a substance that, when added increases flexibility, workability and elasticity of materials such as polymers or cement. They can chemically react or physically interact with polymers and thereby determine the physical properties of the polymer products.
Plasticisers can be used to lower the glass transition temperature of adhesives or sealants in order to improve for example low temperature performance or they can be added to cement in order to improve low temperature performance and workability. Plasticiser exhibit flexibility and elongation and thus improve materials (where introduced) to thermal expansion differences due to seasonal and daily temperature variations.
While the plasticiser itself is subject to registration, if it meets the necessary requirements, any substance generated as a result of chemical reaction when the plasticiser functions as intended, is exempted from registration, provided it is not itself manufactured, imported or placed on the market.
Example:
Dioctyl adipate (DOA) is used as plasticiser in food packaging material as it has a good stability to temperature (heat and cold) characteristics.
Precipitation inhibitors
Precipitation is the process of separating a substance from a solution as a solid. Inhibitors are substances which inhibit or prevent the processes needed for this to take place. Therefore precipitation inhibitors inhibit or prevent the formation of a solid in a solution.
While the precipitation inhibitor itself is subject to registration, if it meets the necessary requirements,, any substance generated as a result of chemical reaction when the precipitation inhibitor functions as intended, is exempted from registration, provided it is not itself manufactured, imported or placed on the market.
Quality control agents
A quality control agent is a substance used to qualitatively or quantitatively determine a specified parameter in a product for keeping an established quality.
While the quality control agent itself is subject to registration, if it meets the necessary requirements, any substance generated as a result of chemical reaction when the quality control agent functions as intended, is exempted from registration, provided it is not itself manufactured, imported or placed on the market.
Example:
Examples of quality control agents include solutions used for the Karl-Fisher titration techniques. In accordance with these techniques, a series of chemical reactions take place which involve water and the substances constituting the quality control preparations. While the substances in the preparation are subject to registration, the reaction products obtained as a result of the titration are exempted from registration.
Solvent
A solvent is a substance, which is used to dissolve a solid, liquid or gaseous substance (solute), forming a solution. While the solvent itself is subject to registration, if it meets the necessary requirements, any substance generated as a result of chemical reaction when the solvent functions as intended, is exempted from registration, provided it is not itself manufactured, imported or placed on the market.
Example:
Polyethylene glycols can form solvation complexes with metal salts when they are dissolved in the glycol. The products of these solvation reactions that occur upon end use do not need to be registered (unless the complex itself is placed on the market).
Stabiliser
A stabiliser is a substance which, when added, prevents unwanted changes of other substances.
While the stabiliser itself is subject to registration, if it meets the necessary requirements, any substance generated as a result of chemical reaction when the stabiliser functions as intended, is exempted from registration, provided it is not itself manufactured, imported or placed on the market.
Example:
Examples of stabilisers are polymerisation inhibitors. For instance, tert-butyl catechol is added to styrene, a monomer susceptible to polymerise spontaneously in the presence of a radical source. The mechanism of action of tert-butyl catechol is based on its ability to chemically react with radicals and by this mean scavenging the initiation of the polymerisation.
While the registration provisions apply to the manufacture or import of tert-butyl catechol, the substances formed upon its reaction with radical initiators are exempted from registration as such.
Surfactants
A surfactant is a surface active agent, i.e. a substance that, because of its design, seeks out the interface between two distinct phases, thereby altering significantly the physical properties of those interfaces through the modification of some superficial or interfacial activity. The interfaces can independently be liquid, solid or gaseous immiscible liquids, a solid and a liquid.
While the surfactant itself is subject to registration, if it meets the necessary requirements, any substance generated as a result of chemical reaction when the surfactant functions as intended, is exempted from registration, provided it is not itself manufactured, imported or placed on the market.
Example:
The manufacture or import of a surfactant used for the waterproofing treatment of leather is subject to registration. However, when the surfactant chemically reacts with the surface of the leather the substances that are generated in this reaction are exempted from registration, provided they are not themselves manufactured, imported or placed on the market.
Subparagraph (b)
In this section, the group of substances exempted from the registration provisions is an extension of the list of substances provided in subparagraph (a). Whenever a substance is used with the aim of providing a specific physicochemical characteristic and where a chemical reaction takes place for the purpose of this application, the substances thus produced do not have to be registered, provided that these substances are not themselves manufactured or placed on the market. The substance produced and its risks shall be assessed through the life-cycle assessment of the precursors/reactants of the reaction.
EmulsifierAn emulsifier is a substance which stabilises an emulsion, frequently a surfactant.
For example detergents are a class of surfactants that physically interact with both oil and water, thus stabilising the interface between oil or water droplets in suspension.
While the emulsifier itself is subject to registration, if it meets the necessary requirements, any substance generated as a result of chemical reactions when the emulsifier functions as intended, is exempted from registration, provided it is not itself manufactured, imported or placed on the market.
Lubricants
A lubricant (as already described in section 4a xix) is a substance that reacts with the surface of a metal to provide a physically attached 'oil' layer. Non-liquid lubricants include grease, powders (e.g. graphite, PTFE, molybdenum disulfide, tungsten disulfide), teflon tape used in plumbing, air cushion and others.
While the components of the lubricant itself are subject to registration, if they meet the necessary requirements, any substance generated as a result of chemical reactions when the lubricant functions as intended is exempted from registration, provided it is not itself manufactured, imported or placed on the market.
Viscosity modifiers
A viscosity modifier is a substance that is widely used to control the flow of liquids in industrial processes. For example, in oil drilling polyanionic cellulose is added to water- based drilling fluids as thickeners to modify fluid flow. In the lubrication industry, viscosity modifiers are added to lubricant oils to vary the fluid flow as a function of temperature. In the latter case, the modifiers are typically polymeric molecules that are heat sensitive, in that the contract or relax depending on temperature.
While the viscosity modifier itself is subject to registration, if it meets the necessary requirements, any substance generated as a result of chemical reactions when the modifier functions as intended, is exempted from registration, provided it is not itself manufactured, imported or placed on the market.
Solvent
A solvent is a substance, which is used to dissolve a solid, liquid or gaseous substance (solute), forming a solution.
While the solvent itself is subject to registration, if it meets the necessary requirements, any substance generated as a result of chemical reaction when the solvent functions as intended, is exempted from registration, provided it is not itself manufactured, imported or placed on the market.
For example, if water is added to a salt (e.g. CuSO4), ionic pairs in equilibrium are formed in solution as a result. Further examples concerning ionic mixtures where water is used as solvent and functioned as intended are given in Attachment 1 at the end of this guidance document.
Note: Water is listed in Annex IV of Regulation (EC) No 1907/2006 as amended by Regulation (EC) No 987/2008 of 8 October 2008 and therefore exempted from registration.
Was dit artikel nuttig?
Dat is fantastisch!
Hartelijk dank voor uw beoordeling
Sorry dat we u niet konden helpen
Hartelijk dank voor uw beoordeling
Feedback verzonden
We stellen uw moeite op prijs en zullen proberen het artikel te verbeteren