Optima Chemical Provides Insight on How to Navigate EU’s Regulatory Landscape when Exporting Specialty Chemicals
By Gene Williams, President of Optima Chemical
According to a report entitled “Impacts of the COVID-19 pandemic on EU industries” by the European Parliament, “Europe is the second largest chemicals producer in the world after China and owns 16.9% of the total global sales.”
Unfortunately, the impact of COVID-19 on Europe’s chemical industry was severe. The report goes on to say that “overall demand for chemicals [in the EU] featured severe shocks across many end-markets, mainly due to disruptions in global supply chains, drops in consumption, and ultimately in manufacturing. The fall in demand for chemicals inevitably resulted in shrinking production and reduced supply.” This shifted priorities in the chemical industry and soon demand for chemicals was seen amongst essential businesses like the medical and food sectors during the height of the pandemic, wherein supplies of critical chemicals were secured for supply chains in these segments of the marketplace. Then in September of last year, chemical output increased dramatically. In fact, research from the European Parliament report indicates that “Q3 experienced an increase of 6.1% from the previous quarter. Output performance, however, was highly country dependent, with some EU Member States experiencing growth from 2019 (e.g. Spain and Poland, with an increase of about 5% in September) and others featuring pitfalls (e.g. France and Italy, with -11.7% and -6.7% respectively).”
This represents an opportunity for U.S. based toll manufacturers to export necessary chemicals to companies in Europe in order to close the supply chain gap and capitalize on the increased demand. As a toll manufacturer itself, with experience in exporting specialty chemicals to other countries, has compiled the below tips for other toll manufactures to consider when contracting with EU based companies.
Understanding the European regulatory environment – REACH
In a factsheet compiled by the European Chemicals Agency (ECHA), toll manufactures need to be aware of the responsibilities required of them under the REACH (Regulation EC 1907/2006 on the Registration, Evaluation, Authorization and Restriction of Chemicals) regulation, which governs the safe use of chemicals in Europe. More specifically, the legislation manages the health and environmental risks associated with while also providing pertinent information to certain players across the supply chain. Since it impacts a vast array of industries –from aluminum, automotive, household cleaners, textiles, to computers – REACH applies to nearly every type of chemical manufactured, imported, or utilized in the European Union.
Therefore, it is essential that toll manufacturers, like Optima Chemical, are aware of the many requirements that need to be met under REACH. First is the obligation to register any substance. The factsheet states that “any EU-manufacturer of a substance in a quantity of one tonne or more per year must register the substance, unless specific exemptions apply. This includes substances on their own, in mixtures or substances in articles when they are intended to be released under normal or reasonably foreseeable conditions of use. If the above-mentioned criteria for registration are met, it is the toll manufacturer who has the registration obligation under REACH, despite the fact that the customer owns the raw materials, intellectual property and end product(s).” The toll manufacturer must also ensure that the use of the substance being produced, or even the raw materials being used in the manufacturing of a specialty chemical, are not restricted under REACH’s Annex XVII. “This information should be indicated by the supplier of the substance, usually in the safety data sheet (SDS). If the substance is listed in Annex XIV to the REACH Regulation, the toll manufacturer must check whether or not [it] needs to apply for an authorization for use. However, if an authorization for this specific use has been granted to an actor up [its] supply chain (e.g. the customer) the toll manufacturer may benefit from it (provided that [it] uses the substance according to the conditions of an authorization granted to an actor up [its] supply chain).”
Next is the requirement for safety data sheets (SDSs) by thew supplier of a substance or mixture under Annex II of REACH. Under this obligation, “the toll manufacturer [is] formally responsible for providing the SDS for the substance(s)/mixture(s) that he manufactures to the customer. However, if agreed between the parties, the compilation of the SDS can be carried out by the customer.” Furthermore, the toll manufacturer must be able to “demonstrate REACH compliance upon request of (inspecting/enforcing) authorities or ECHA,” which includes information like registration numbers of substances manufactured, a copy of the tolling contract, and SDSs of substances/mixtures that are manufactured for the customer or made available by the customer.
Finally, there is the issue of confidentiality among customers and toll manufacturers, something that is expressly protected under REACH, particularly given that the customer may not want to reveal the identity of its toll manufacturer to its end client(s), “or to disclose that there are other tollers acting on his behalf.” In this instance, the ECHA’s factsheet states that toll manufacturers can obtain a “Third Party Representative (TPR) for discussions with other registrants within the Substance Information Exchange Forum (SIEF) for a phase in substance. The toll manufacturer might appoint the customer as a TPR. In this case the identity of the registrant (i.e. the toll manufacturer) will not be disclosed to other manufacturers or importers by ECHA in the inquiry process. As a TPR, the customer will be a visible participant in discussions in any SIEF for the individual substances concerned. However, when concluding SIEF agreements and agreements for access to data the specific status of the TPR needs to be taken into account. It needs to be ensured that the actual registrant (i.e. the toll manufacturer), who is represented by the TPR, also obtains permission to refer to the data in the joint registration.”
Global Toll Manufacturers Can Offer a Solution
As demand for specialty chemicals continues to increase globally, toll manufacturing remains a growing segment of chemical production in the current supply chain ecosystem, given the cost-effective advantages it offers to a broad range of companies, including start-up organizations that might be looking to get a product to market quickly or companies that only require small batches of product for prototyping purposes. Additionally, with all of the stringent regulatory requirements in place across the globe today, specialty toll manufacturers make especially fruitful partners because most are already compliant with current regulations such as safe labelling, transport and hazard regulations. But selecting a reliable toll manufacturer can be difficult if you don’t know what to look for in a partnership.
As a leading global supplier of specialty chemicals, toll services, and custom manufacturing, Optima Chemical has a long-standing track record of providing customers with solutions to their own internal manufacturing limitations by helping them bridge volumes for new product launches and handling specialist chemistries that are not core to their own expertise. Therefore, selecting a like Optima Chemical means you are partnering with an experienced and well-recognized provider of chemical toll manufacturing services to a broad range of chemical markets. Optima Chemical is known in the marketplace for providing fast and reliable engineering and manufacturing solutions that meet our customers’ individual requirements, whether that’s in our existing toll manufacturing plant or in a new build. Our fast, reliable engineering and toll manufacturing solutions for chemical markets means Optima Chemical can get new equipment and plant installations up and running quickly. Most importantly, Optima Chemical offers our customers: capital resources and amortize cost over production; the ability to move quickly on capital projects from installation to start-up; and comprehensive scale and unique manufacturing capabilities.
Whatever the circumstances, the fact remains that toll manufacturing has proven to be a winning proposition for many customers worldwide and will undoubtedly continue to be the right choice for a variety of source companies now and into the future.
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