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Der Elektrolyseur-Hersteller Enapter mit Hauptsitz in Italien baut im nordrhein-westfälischen Saerbeck eine Produktionsstätte (Fotosimulation). Sie bündelt auf 82 000 Quadratmetern Produktion, Forschung und Entwicklung, Verwaltung und eine Kantine. Mit Forschenden von Fraunhofer Umsicht, Wupperta...

Schlaglichtthema: Chemie in Europa

Why chemists should know about their downstream users, and how legislation defines them. They are neither distributors nor consumers.
Chemistry has many branches, and chemicals are needed to make all materials, and products used by society. To make a product, chemicals must go through various steps.
In a highly simplistic description, chemical manufacturers produce chemical substances in the first step of the supply chain. These substances are then used by next actors in the supply chain to make products. They are combined to form chemical mixtures such as glues or paints. They are included into more solid articles, such as plastic packaging and metal pieces in cars. The entities acting in this middle ground of the supply chain are termed downstream users. Ultimately, an end user &ndash; a consumer, a professional, or a worker &ndash; uses the final product for the intended application.
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<figure><img alt="image" src="https://media.graphassets.com/SwDhB8fSlTvCGudfJ1wg" />
<figcaption><label>Abb.1: </label>Three steps in the supply chain of chemicals. In the middle various downstream users form chemical mixtures and include them in more solid articles.</figcaption>
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The legal definition of the term downstream users, according to the Registration, Evaluation, Authorisation and Restriction of Chemicals Regulation (EU-regulation Reach) is: &bdquo;any natural or legal person established within the community, other than the manufacturer or the importer, who uses a substance, either on its own or in a mixture, in the course of his industrial or professional activities. A distributor or a consumer is not a downstream user.&ldquo;
Legal definitions are important and relevant to chemists. Products on the European market need to comply with various regulatory requirements, and chemists wishing to use their skills to place products of any kind in the EU must be aware of the legal framework that these products need to follow.
Products such as cosmetics, detergents, aerosols, paints, inks, toners, pressroom chemicals, adhesives, sealants, construction chemicals, fragrances, lubricants, as well as the crop protection and chemical distribution industries, are affected by both horizontal and sectoral legislation. Horizontal legislation, such as the Reach regulation, is applicable to all chemical products. Meanwhile, examples of more sector-specific legislation are the Cosmetics Regulation and the Sustainable Use of Pesticides Directive.
<h2 type="main">Formulating downstream users</h2>
Cosmetics, detergents, aerosols, paints, inks, toners, adhesives and sealants, construction chemicals, fragrances, lubricants, crop protection, and chemical distribution. What do all of these industries have in common?
They are downstream users. They are formulating industries.
Formulation chemistry is a branch of chemicals manufacturing that deals with substances that typically don&rsquo;t react with each other but contribute to a final product in some way. For example, a paint may be made of pigment (to provide the desired colour), binder (to hold pigment particles together on the surface), a solvent (carrier, dissolver), etc. These don&rsquo;t react with each other, but all play a role in the final product.
A good analogy to formulation is baking, where ingredients are added in different ratios according to a recipe, however with considerable additional complexity. A formulation is likely to be made many more times than baked goods prepared by any amateur or even professional baker. Also, the level of precision in weighing, analysing, and recording observations will be much higher during industrial research. A formulation cannot have significant variability between batches. Customers expect paints, detergents, adhesives, and other formulations to always have consistent texture, pourability, and colour.
Companies cannot consider only the mixing step of the single product but also need to ensure other aspects, for example:
<list><listitem>The product must go through the pipes of the manufacturing plant.</listitem><listitem>It must remain in the container in such a way that it can be functionally used by an end user.</listitem><listitem>It&rsquo;s important to reduce the amount of product that remains as waste inside packaging.</listitem><listitem>You don&rsquo;t want your product to spoil.</listitem></list>
Even if no reaction chemistry takes place within such a complex product, formulators must ensure that all ingredients do not negatively affect the overall performance of the product (stability, miscibility, colour, odour, etc.).
The commonalities of these industry sectors, combined with their common interest in regulatory requirements that these sectors must consider to place safe, sustainable and compliant products on the market, led to the creation of the Downstream Users of Chemicals Co-ordination group (DUCC).
<h2 type="main">How does a European organisation help?</h2>
DUCCis a platform of eleven associations re-presenting downstream formulating industries. The objective of the group is to contribute, with a common voice, to the implementation of chemicals legislation.
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<figure><img alt="image" src="https://media.graphassets.com/flJz5OMsSlOKKHdFTyFv" />
<figcaption><label>Abb.2: </label>Members of the Downstream Users of Chemicals Co-ordination Group (DUCC) and the impact of regulation.</figcaption>
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In 2021 DUCC celebrated its 20-year anniversary. For the past two decades the organisation has worked to support different industries in implementing important regulation. Key topics pursued by DUCC have included several aspects of communication and guidance:
With regard to supply chain communication, DUCC members have a long-standing history of engaging in dialogue with other stakeholders to find pragmatic solutions to improving the tools for communicating information on safe use of chemicals within the supply chain (i. e., safety data sheets and exposure scenarios). DUCC members have worked to ensure that these are better understood within industry and provide relevant information.
In addition, DUCC members are also engaged in improving communication on chemical products, especially to consumers, through simpler labels and by leveraging the potential of digitalisation.
DUCC has also acted to provide guidance to support companies. For instance, in collaboration with sector organisations representing retailers, DUCC is raising awareness of the regulatory obligations for the classification, labelling, and packaging. One noteworthy initiative is providing guidance for online sales, which aims to raise awareness of the legal requirements when selling products online.
<h2 type="main">Future plans for DUCC and EU chemists</h2>
Now, due to the European Commission&lsquo;s plans for the EU Green Deal, many pieces of legislation that affect the chemicals sector will go through revisions and updates, with subsequent crucial impacts on how products will be produced in the EU; it is even possible that some products will no longer be accessible in the future. Additional requirements will be imposed on companies to set a higher bar &ndash; and increase the requirements towards what is considered a safe and sustainable product. DUCC will continue to be engaged with the aim of successfully implementing EU legislation. In the context of this change, DUCC encourages European chemists to inform themselves about the upcoming changes. All products are made with chemicals and it is crucial that Europeans remain engaged in chemistry in the future. We must maintain and develop talent in Europe that can lead us to build opportunities towards safer and more sustainable products as well as a strong European industry.
<h2 type="main">Die Autorin</h2>
The article was written by Giulia Sebastio, Scientific and Regulatory Affairs Manager at Downstream Users of Chemicals Co-ordination Group (DUCC). Giulia has a background in chemistry and has worked as a chemist and regulatory affairs professional across different fields including chemicals, food products and pharmaceuticals. As a DUCC manager she aims to bring together the voices of all DUCC members towards cooperation and a unified voice. <a href="https://www.ducc.eu" target="_blank" rel="noopener">www.ducc.eu</a><img alt="image" src="https://media.graphassets.com/UDc5b8I7SLedp5BXkqak" />

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