If you have Substances of Very High Concern (SVHCs) with a concentration above 0.1 mg/kg per material in your products, you are required to report this as of 5 January 2021 by entering the concentrations, the components and the test documents in the new SCIP database. In Germany, at present there is only an informal obligation to report to the ECHA, the European Chemicals Agency, pursuant to Section 16f of the Chemicals Act (ChemG), which does not include the obligation to actually use the SCIP database. It remains to be seen how long this German path can be maintained. If you wish to set up your business in a future-proof way or sell your products to other EU countries, you will probably not be able to avoid using the SCIP database.

As reported by our partner VFI/German Importers, the SCIP database already contains more than 50,000 notifications one month after activation. Seven per cent of attempted registrations in the database are reported to have been unsuccessful due to the validation rules. These included e.g. multiple filings of a product by the same company or attempted registrations of companies outside the European Union.

Are your products SVHC-free? You will only know this once you have valid test documents in hand. However, many products can already be seen to contain SVHCs. The new transparency of the publicly accessible SCIP database is a real invitation to establish whether such products are on record in the database. Both market participants and regulatory authorities can give you cause for concern when you take this path.

As already reported in April, according to the European Chemicals Agency (ECHA), the notification of articles containing SVHCs is mandatory from 5 January 2021, following the amendment to EU Directive 2018/851. SVHC stands for “Substances of Very High Concern”. All articles containing more than 0.1% by mass of SVHC substances are subject to mandatory notification. Many other electrical and electronic equipment may also be affected, as heavy metal compounds and flame retardants are also included in the SVHC list. For purposes of specifying the EU SCIP (Substances of Concern in articles as such or in complex objects (Products)) database has now been completed. Entry of SVHC substances is mandatory as of 5 January 2021. Please make timely preparations for such mandatory notification so that you or your suppliers have sufficient lead time until 5 January 2021.

On 3 November 2020, the EU Commission updated the standards harmonised under the EMC Directive 2014/30/EU. New extensions to standards now apply in particular to industrial, scientific and medical equipment, household appliances, power tools and similar instruments, electrical lighting equipment and similar electrical appliances and similar electronic, multimedia and switchgear equipment. Manufacturers, importers and authorised representatives relating to the aforementioned devices must therefore check whether the test reports on which the market conformity of their products is based have lost their validity.

According to the European Commission, stricter threshold values for 33 carcinogenic, mutagenic or reprotoxic chemicals came into force on 1 November 2020. The new threshold values are based on the EU REACh Regulation, which offers the highest level of protection for human health and the environment in the world. The EU’s REACh Regulation was adopted to improve the protection of human health and the environment from possible risk exposure to chemicals, while simultaneously increasing the competitiveness of the EU chemicals industry.

On 14 October 2020, the European Commission adopted the EU Chemicals Strategy for Sustainability. The strategy is the first step towards the zero-emissions target for a pollution-free environment announced as part of the European Green Deal. The strategy will foster and promote innovative solutions for safe and sustainable chemicals and increase the level of protection of humans and the environment from hazardous chemicals. This includes a ban on the most harmful chemicals in consumer products such as toys, childcare articles, cosmetics, detergents, food contact materials and textiles, unless they can be shown to be essential for the general good or public welfare.

According to the European Chemicals Agency (ECHA), the Committee for Socio-economic Analysis (SEAC) supports the proposal to restrict the use of skin-sensitising substances in textiles, leather, imitation leather and fur articles placed on the market for the first time.

In order to validate the REACh declaration, trade-e-bility will assist you with the document analysis. The declaration must be absolutely correct without fail, otherwise conventional penalties or claims for damages may be filed by customers and the goods cannot be sold as planned.

The long list of rules makes it clear why now is the right time to tackle the topic of the Market Surveillance Regulation. You do not need to be concerned, however. After all, we have taken precautions for you and have developed business solutions over the last several years which are now available to you to deal with the daunting Market Surveillance Regulation.