CE conformity: Selected important updates of the last 2 years.

CE conformity: Selected important updates of the last 2 years.

It is essential for manufacturers and distributors of affected products to continuously check the validity of the directives in the CE conformity system. In the following, the focus is on innovations and updates of the following selected directives:

1. 2006/42/EC - Machinery Directive
2. 2011/65/EU - RoHS Directive
3. 2014/30/EU - Electromagnetic Compatibility Directive
4. 2014/35/EU - Low Voltage Directive)
5. 2009/48/EC - Toy Safety Directive

I. Policy-level updates

The latest amendments to the EU Electromagnetic Compatibility Directive 2014/30/EU were published on 04.07.2018 and deal with regulations and safety requirements in civil aviation and aviation safety.

The following changes to selected directives are listed here.

1. 2006/42/EC - Machinery Directive
- Regulation (EU) 2019/1243 of the European Parliament and of the council of 20 June 2019

The most recent update of the Directive 2006/42/EC on machinery is EU Regulation 2019/1243 dated 20.06.2019. Primarily, the Commission is here given the authority to update extensions and amendments to the non-exhaustive list of safety components (Annex V).

2. Directive 2011/65/EU - RoHS Directive
- The RoHS (= Restriction of Hazardous Substances) directive has a large number of updates.

For example:
- Delegated Directives (EU) 2019/1845 and 2019/1846
- Delegated Directives (EU) 2019/169-178

The Delegated Directives (EU) 2019/169-178 regulate among other things the exceptions for lead and cadmium, e.g. in electrical contacts, printing inks or crystal glass. The new Delegate Directives (EU) 2019/1845 and (EU) 2019/1846, regulate the exceptions to the bans on the use of two substances (1. lead in solders and 2. rubber components, both for engine systems). The restrictions of the substances are regulated in Annex II of Directive 2011/65/EU. Delegated Directive (EU) 2019/1845 includes an exemption for di(2-ethylhexyl)phthalate (DEHP) in used rubber components of certain engine systems. In addition, Delegate Directive (EU) 2019/1846 provides for an exemption for lead used in solders for engine systems.

3. Directive 2014/30/EU - Electromagnetic Compatibility Directive
- Regulation (EU) 2018/1139 of the European Parliament and the Council of 04.07.2018

The latest amendments to the EU Directive 2014/30/EU relating to electromagnetic compatibility were published on 04.07.2018 and deal with regulations and safety requirements in civil aviation and aviation safety.

4. 2014/35/EU - Low Voltage Directive
- No policy-level update

5. 2009/48/EC - Toy Safety Directive
- Directive (EU) 2018/725

In the Toys Directive, the EU Directive 2018/725 also contained an adaptation concerning the safety requirements for chromium VI.

II. Updates of the harmonized standards

The various harmonized lists of standards are adapted by the European Commission with a time lag and published in notices. The consolidated lists of standards give a good overview of the updates concerning the standards and when they become invalid or are replaced if necessary to prove conformity with the directive.
Some of the most important updates to the harmonized standards (Official Journal) are as follows:

2006/42/EC - Machinery Directive
In the Directive 2006/42/EC on machinery there are as many updates regarding the applicable harmonized standards as in the Low Voltage Directive.One of the most comprehensive product groups here is probably that of electric, motor-driven and hand-held tools. For example, on 21.08.2019 the standard EN 60745:2010 was provided with the additional standard EN 62841:2014.

2011/65/EU - RoHS Directive
The new harmonized standard EN IEC 63000:2018 was included in the RoHS directive on 18.05.2020. Among other things, this standard regulates the technical documentation for electrical and electronic equipment.

2014/30/EU - Electromagnetic Compatibility Directive
No update for harmonised standards after 2017.

2014/35/EU - Low Voltage Directive
In the Low Voltage Directive, there have been a large number of changes to the harmonized standards for products such as automatic electrical control equipment, low voltage switchgear, audio and video equipment, switches, luminaires.
An important change here is, for example, the IEC/EN 62368-1:2014 standard for audio/video, information and communication technology equipment. From 20.12.2020 this replaces the standard EN 60065:2014 and the standard EN 60950:2006.

2009/48/EC - Toy Safety Directive
Among the harmonized standards of the Toy Safety Directive there is an amendment to the standard EN 71-3:2013 + A3:2018, Safety of Toys - Part 3: Migration of certain elements, which lost its validity on 15/04/2010. The new standard EN 71-3:2019 includes new limit values for chromium and adapted test methods for the migration of certain elements.

III. Outlook

Due to the complexity, only the most relevant updates could be discussed here. It becomes clear which challenges and requirements arise for manufacturers of CE-relevant products in terms of permanent monitoring and interpretation of measures. Not only in the sense of increasing monitoring at EU level, consistent monitoring of changes and innovations in terms of the duty of care for manufacturers and distributors is essential.

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