take-e-way News on EPR & Product Compliance

04/09/2020

Selling medical respiratory masks without CE marks

While so-called “community masks” without the CE mark can be placed on the market, these are not suitable for use in the clinical sector, for instance. However, for medical respiratory masks which are also marketable in the United States of America, Canada, Australia or Japan, Section 11 (1) of the German Medical Devices Act allows the competent authority to issue special permits and, where necessary or applicable, also to declare such masks without CE marks as marketable in Germany.

04/09/2020

Please observe timely the notification obligation for articles containing SVHC as of 5 January 2021

As of 5 January 2021, notification of articles containing SVHCs is mandatory according to 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 compulsory notification. In particular, articles such as CdTe photovoltaic modules are subject to notification due to their product characteristics. Many other electrical and electronic equipment may also be affected, as heavy metal compounds and flame retardants are also included in the SVHC list. Recommendation: Please make timely preparations for such mandatory notification so that you or your suppliers have sufficient lead time until 5 January 2021.

04/09/2020

Observe POP (Persistent Organic Pollutants) limits for flame retardants

On 20 February 2019 the European Parliament agreed on new limit values for brominated diphenyl ethers, which are used as flame retardants. Polybrominated diphenyl ethers (PBDE), already known through the RoHS Directive, are now newly governed by this resolution, with the limit value being halved, i.e. massively reduced. For decabromdiphenylether (DecaBDE) the RoHS limit value continues to apply to electrical equipment. This affects distributors, importers and manufacturers since the materials of products may only contain a total of 500 mg/kg of BDEs (brominated diphenyl ethers); for decaBDE as a single substance, the limit is 10 mg/kg. Recommendation: The agreement is not yet legally binding. However, please make sure that your suppliers already have products that meet the above requirements.

04/06/2020

Requirements relating to Breathing Masks from Manufactories (“community masks”)

The provision of breathing masks from manufactories (“community masks”) is possible if certain rules are followed. The decisive factor is the correct labelling of the masks, which must be clearly distinguishable from medical products or personal protective equipment. Affected manufacturers and importers of breathing masks that do not comply with the Medical Products Act must observe the requirements of the Product Safety Act.

04/06/2020

German Packaging Act: Effects of the Corona Pandemic on the Declaration of Completeness by 15 May 2020

The obligation to submit a declaration of completeness only applies if the volume of packaging placed on the market that is subject to the system participation obligation reached one of the three following quantity thresholds in the previous calendar year: 80,000 kg of glass; 50,000 kg of paper, cardboard, carton; 30,000 kg of ferrous metals, aluminium, plastics, beverage cartons, other composites. The 15 May 2020 target date refers to the statutory deadline over which the German Central Packaging Register has no influence.

04/06/2020

Automotive and Industrial Batteries: Documentation of the Performance Review for 2019 to be submitted to the German Federal Environment Agency by 30 April 2020

According to the provisions of Section 15 of the German Battery Act, distributors of automotive and industrial batteries are obliged to submit an annual documentation of their performance review (collection, take-back and recycling) to the German Federal Environment Agency. The performance review must be submitted to the Federal Environment Agency by 30 April 2020.

04/01/2020

Corona crisis: Simplification measures for placing disinfectants on the German market

Between 4 March and 26 March 2020, as many as three general decrees of BAUA (Federal Institute for Occupational Safety and Health) were added, which now grants special approvals for certain hand disinfection formulations. These can now be produced industrially also for normal consumers, without any supply restrictions. Recommendation: In order to avoid supply bottlenecks for the manufacturers listed under the Biocides Ordinance, the current BAUA general decree should be used.

04/01/2020

WEEE Germany/ElektroG: Corona impacts on the annual statistical notification

On account of the current corona pandemic, the EAR Foundation, in coordination with the German Federal Environment Agency, has decided to give all parties obliged to notify the opportunity to submit their annual statistics notification for 2019 on the EAR portal by 31 May 2020. Notifications submitted after 30 April 2020 – which are actually late – will therefore not be forwarded (in coordination with) the Federal Environment Agency as the authority responsible for the prosecution of administrative offences.

04/01/2020

Consumer products: Stricter rules for use of pthalates as of 7 July 2020

Please ensure that your suppliers have already checked the products for substances in the prohibited list according to Annex XVII of REACh. Moreover, we recommend that you arrange for your suppliers to sign a declaration of chemical harmlessness. Also ensure for production that none of the phthalates mentioned can “creep in” unnoticed.

03/25/2020

Corona crisis: Simplified conformity procedure for breathing masks

The EU has simplified the procedure for supplying the EU market with a recommendation to notified bodies for respiratory masks. Respiratory masks are considered personal protective equipment of category III and are subject to mandatory certification. The certification procedure is now faster and more cost-effective. The company trade-e-bility GmbH provides assistance with the preparation of the documents, the marking of the masks and the issuance of the necessary EU conformity declaration.

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