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Updates

New updates, improvements, and notable regulatory changes.

Research Shows Harmful Substances in Childcare Products

Chemical substances causing cancer, genetic mutations or harming reproduction (CRM) are widely present in childcare products, such as car seats, bibs, and baby changing mats.

ECHA
Research Shows Harmful Substances in Childcare Products
Photo by National Cancer Institute / Unsplash

The European Chemicals Agency (ECHA) has found that substances causing cancer, genetic mutations or harming reproduction are present in childcare products, such as car seats, bibs, and baby changing mats. The findings published on November 8 2023 show that there is a need for stricter market surveillance, and further regulation.

ECHA’s investigation, drawing on information from 48 different sources, shows that substances which are carcinogenic, mutagenic or toxic for reproduction (CMR) may be present in childcare products (articles). Metals like cobalt and lead, along with phthalates like DEHP, are the most common CMR substances found in childcare products.

CMRs

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EU Commission Extends Effective Date of Expanded Radio Equipment Requirements

The European Commission has extended the effective date of its expanded application of the essential requirements of its Radio Equipment Directive (2014/53/EU).

RED

The European Commission has extended the effective date of its expanded application of the essential requirements of its Radio Equipment Directive (2014/53/EU, also known as RED). Delegated Regulation (EU) 2023/2444, published in late October in the Official Journal of the European Union, extends until August 2025 the expanded application of the RED detailed in Delegated Regulation (EU) 2022/30. That Delegated Regulation includes the cybersecurity of internet-connected equipment under the scope of the RED and was originally scheduled to take effect in August 2024.

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Six Balkan Countries to Join the EU Single Market

Albania, Bosnia, Kosovo, Montenegro, North Macedonia, and Serbia to join the EU Single Market.

The European Union (EU) has revealed a growth plan for six Western Balkan countries - Albania, Bosnia, Kosovo, Montenegro, North Macedonia, and Serbia. This plan offers these countries access to parts of the EU single market in exchange for substantial reforms. The reforms include improving the regulatory structure for business, fighting corruption, and eliminating organised crime.

The EU's new growth plan allows these countries to enter the EU market in specific areas on a case-by-case basis, provided they demonstrate the required reforms. The areas include goods and services, road transport, energy, electricity, customs cooperation, e-commerce, and cashless payments.

Countries that

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The European Commission has published an update to the list of harmonised standards for the Radio Equipment Directive (2014/53/EU) with a number of corrections.

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Amendment standards under Personal Protective Equipment Regulation (2016/425)

The European Commission amends the list of harmonised standards under the Personal Protective Equipment Directive 89/686/EEC

Do you have applied standards to prove compliance in regard to the mentioned regulations? We recommend you to check the new list of standards to see if any of the standards you applied have been updated. If so, you need to re-evaluate your products against the updated standard and update your Declaration of Conformity. See the amendments here

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UK REACH: Deadline Extended until October 2025, published December 2021

The UK government wants to extend the deadline for registrations in the new REACH database. The plan is to extend until October 2025. This is a two-year delay. This gives industry extra time to implement a new safety regime for chemicals. The British industry pertinently opposed to the current plans to set up a new UK chemical safety database. Already in February 2021, the industry demanded an extreme rethink of the existing plans. These will, according to their figures, cost the industry £1 billion.

UK REACH: Deadline Extended
UK REACH: Deadline Extended | Photo Source:
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Amendments Toy Safety Directive 2009/48/EC as published in November 2021: a summary

The European Commission has made changes to the list of harmonized standards under the Toys Safety Directive. These have been published on 16-11-2021. In this article, we summarize the standards on the list that have been amended.

Amendments Toy Safety Directive
Amendments Toy Safety Directive | Graphics: Ellina Goncharova from Alura Group

The following standards are replaced with effect from 28 November 2021:

  • EN 71-7:2014+A2:2018 (Part 7: Finger paints – Requirements and test methods) is replaced by EN 71-7:2014+A3:2020 (Part 7: Finger paints — Requirements and test
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Pressure Equipment Directive 2021 revision Amendment
2021 Amendments Pressure Equipment Directive | Photographer: CHUTTERSNAP | Source: Unsplash

The amendments to harmonised standards under the Pressure Equipment Directive (PED) are published in an executive order. These took effect on October 11, 2021. It covers the harmonized standards for:

  • metallic industrial piping systems;
  • bolted connections for flanges and their joints;
  • flame tube boilers made of corrosion-resistant steel.

Article 12 of Directive 2014/68/EU

In accordance with Article 12, pressure equipment or assemblies thereof [1] shall be presumed to conform to the essential safety requirements [2].

[1]: Article 4(1) and (2) refer to assemblies which are in conformity with

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Europe: Eight New Substances in the SVHC Candidate List

Retailers, brands and manufacturers must notify ECHA about any substance limit over 0,1% in their articles, within six months from the inclusion of that substance in the Candidate List.

You can read all about it [HERE] on ul.com

Europe: Eight New Substances in the SVHC Candidate List
Europe: Eight New Substances in the SVHC Candidate List | Photographer: Trnava University | Source: Unsplash
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Notice of anullment
Notice of annulment

The European Commission published a notice of annulment of the Commission Delegated Regulation (EU) No 665/2013 on energy efficiency labeling requirements for vacuum cleaners. This follows a ruling of the General Court of the European Union in November last year in a case brought forward by the company Dyson. The Commission did not appeal and the annulment became in effect on 19 January 2019.

This has the following consequences from 19 January 2019 onwards:

  • Suppliers may no longer place vacuum cleaners on the Union market accompanied by the energy label as was provided for by Commission Delegated Regulation (EU)
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European Commission Publishes Updated Borderline & Classification Manual

On October 30, 2018 the European Commission published a new version of the Borderline & Classification Manual. This manual is intended to provide guidance on the status of medical devices and in vitro diagnostics and their risk classifications.

The manual adds six new items: two to help determine medical intended purpose, one for classification and three about mobile software.

Borderline ? medical intended purpose

1. Mattress covers against mites (not considered a medical device); 

2. Lubricants intended for body massages and/or to help sexual intercourse; (lubricants for body massages or that are intended only to stimulate sexual intercourse are

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List of harmonised standards
List of harmonised standards

Today, the European Commission has published new lists of European harmonised standards for the following Directives:

  • Pressure Equipment Directive (2014/68/EU)
  • Active Implantable Medical Devices Directive (90/385/EC)
  • Medical Devices Directive (93/42/EC)
  • In Vitro Diagnostics Directive (98/79/EC)
  • Radio and Telecommunication Terminal Directive (1999/5/EC) and Radio Equipment Directive (2014/53/EU)

The PDF documents with the new lists of standards have been added to the CE Marking Library of our online platform already. The new and amended standards are being included in the standards database.

If you have questions, please let us know.

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EN 12312-6 Superseded

On 30 September 2017, the EN 12312-6:2014 + A1:2009 for Aircraft ground support equipment – Specific requirements – Part 6: De-icers and de-icing/anti-icing equipment was supeseded by the version EN 12312-6:2017. The superseded version may not be used as proof of conformity with the Machinery Directive (2006/42/EC).

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Household Standards Superseded

Today, (September 29, 2017), two European harmonised standards for household equipment are superseded.

CE Marking Directives, Regulations and Standards
CE Marking Directives, Regulations and Standards

Today (September 29, 2017), the following European harmonised standards are superseded:

EN 60335-2-23:2003 – Household and similar electrical appliances – Safety – Part 2-23: Particular requirements for appliances for skin or hair care is superseded by version A2:2015.

EN 60335-2-97:2006 – Household and similar electrical appliances – Safety – Part 2-97: Particular requirements for drives for rolling shutters, awnings, blinds and similar equipment and its amendments are superseded by version A12:2015.

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New Lists of European Harmonised Standards Published

On September 8, 2017, the European Commission published a new list of European harmonised standards for the Low Voltage Directive (2014/35/EU) and ATEX Directive (2014/34/EU).

List of harmonised standards
List of harmonised standards

On September 8, 2017, the European Commission published a new list of European harmonised standards for the following directives:

  • the Low Voltage Directive (2014/35/EU)
  • the ATEX Directive (2014/34/EU)

If any of these directives apply to your products, we recommend you to check if the standards you or your suppliers have used have been amended, or that new relevant standards have been included in the list.

The following standards have been added to the list for the Low Voltage Directive:

EN 60335-2-9:2003 – Household and similar electrical appliances - Safety - Part 2- 9: Particular requirements

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