Title of the opening text
Introduction of the citations
Having regard to the Treaty on the Functioning of the European Union, Having regard to [Amending Directive] of the European Parliament and of the Council of [adoption date] on [general subject], and in particular [specific provision of the directive] of that Directive, (each citation is included in a different paragraph)
Recital of regulatory directives that establish obligations, including specific requirements, updates, restrictions, and exemptions
[(number)] [Amending Directive/Articles/Annexes] requires Member States to ensure that [general subject] do not contain the hazardous substances listed in Annex [number] to that Directive. [(number)] [Amending Directive/Articles/Annexes] requires conformity assessment bodies are to comply with the requirements laid down in Annex [number] to become notified bodies. [(number)] Under Article [number] of [Amending Directive], Member States are to prohibit using [general subject]. [(number)] [Amending Directive/Articles/Annexes] require Member States to prepare and update [general subject] every [number] years in line with the requirements set out in that Directive. [(number)] [Amending Directive] applies to [general subject] [(number)] [Amending Directive, Articles or Annexes] prohibits placing on the market [products] with [characteristics to avoid]. [(number)] Article [number] of [Amending Directive] exempts [general subject] from the prohibitions laid down in paragraphs [number] and [number]. [(number)] Sections [number] of Annex [number] to [Amending Directive] refer to provisions set out in [general subject] as defined in Article [number] of that Directive.
Recital of the reference to the information outlined in the annex [optional content]
[(number)] [Amending Directive] applies to the categories of [general subject] listed in Annex [number].
Recital of regulatory restrictions on the use of specific substances [optional content]
[(number)] [Name of the substance] is a restricted substance listed in Annex [number] to [Amending Directive]. [(number)] Commission Delegated Directive (EU) [yyyy/number] added [substances] to the list of restricted substances referred to in Annex [number] to [Amending Directive]. [(number)] Under Commission Delegated Directive [yyyy/number], [name of the substance] is a restricted substance listed in Annex [number] to [Amending Directive]. Its use is to be prohibited from [dd Month yyyy] in [devices]. This applies if [name of the substance] exceeds a maximum concentration value of [decimal number]% by weight in [type of materials] materials.
Recital of an exemption request for a specific substance [optional content]
[(number)] On [day Month yyyy], the Commission received an application made in accordance with Article [number] [Amending Directive] for an exemption to be listed in Annex [number] to that Directive, for the use of [general subject] (‘the requested exemption’). Exemption [number] should be further specified with a narrower scope. This would allow the [type of industry] industry to adapt to those changes. [(number)] By Delegated Directive [yyyy/number], the Commission granted an exemption for using [general subject] ('the exemption'), by including those applications in Annex [number] to [Amending Directive]. [(number)] The exemption was to expire on [dd Month yyyy].
Recital of specific implementation details
[(number)] Using [general subject] should be excluded from the exemption with specific dates. It is necessary to clarify that [relevant aspects on the general subject] should be considered within the [regulatory requirements] under [Amending Directive]. [(number)] Conformity assessment bodies are to ensure that [entities] used for conformity assessment purposes meet the requirements of Standard [Name of the standard]. [(number)] Annex [number] to [amending Directive] lists [regulated items] exempt from the prohibition in Article [number] of that Directive. [(number)] Exemption [number] on the use of [general subject] needs to be amended to align its wording with similar exemptions for the use of [substance] in Directive [yyyy/number] and Regulation [yyyy/number] of the European Parliament and of the Council. [(number)] The aggregation level of [reported information or projections] that [amending Directive] requires no longer matches [international agreement or framework] reporting requirements since the review of the [guidelines on standards]. [(number)] The repeal of [Repealing Directive] by Regulation [yyyy/number] changed the [general subject]. Given these changes, the [general subject] in Article [number] of [Amending Directive] should be updated. The same applies to point [number] of Annex [number] to that Directive. [(number)] To ensure that internal [procedures and organisational] are properly implemented and adhered to, it is necessary to clarify that [processes, systems and internal controls] reflect [risks]. Moreover, it is necessary to clarify that technical capacity and knowledge is necessary to analyse those risks. [(number)] Member States have agreed to include, in justified cases, the notification of their transposition measures with one or more documents explaining how the components of a Directive relate to the corresponding parts of national transposition instruments. This is in accordance with the Joint Political Declaration of [dd Month yyyy] of the Member States and the Commission on explanatory documents. [(number)] To protect the [relevant interests] at a high level, [activities] should take place in [controlled systems]. [(number)] In view of the substantial change of circumstances on [products], Article [number] of [Amending Directive] should be amended to extend [general subject]. [(number)] On the same grounds, Article [number] of [Amending Directive] should be amended. That amendment should withdraw Member States’ possibility to grant exemptions for [type of products] products. [(number)] Periodic [type of test] should be carried out regularly in accordance with [Amending Directive]. [(number)] The rules regarding the integration of [risks] should apply to [entities] to avoid:
a) an uneven playing field for [entities] that have not designated a management company, and
b) related fragmentation, inconsistency and unpredictability in the functioning of the internal market.These rules should take into account the the principle of proportionality. [(number)] [Entities] should include conflicts of interest that may arise as a result of integrating [risks] in their processes, systems and internal controls. This should apply when identifying the types of conflicts of interest that may damage the interests of a [stakeholder]. This is necessary to maintain a high standard of [objective]. [(number)] A maximum concentration of [number]% [general subject] by weight in the [material] is sufficient for the requested exemption.
Recital of detailed evaluations and reports
[(number)] A technical and scientific assessment study was carried out to evaluate the exemption application. [(number)] The assessment of exemption [number] in view of [justification] concluded that suitable alternative substances to [substance] are available although they cannot yet be used in products. [(number)] The assessment of exemption [number] concludes that using [general subject] in the applications covered by that exemption should not be prolonged because there alternatives to using [general subject] in those applications. [(number)] The Report informs and provides istatistics on [developments] which show [indicators] of [products] increased by at least [number]% in at least [number] Member States. [(number)] Evaluating the requested exemption included stakeholder consultations in accordance with Article [number] of [Amending Directive]. [(number)] Evaluating the renewal request included stakeholder consultations in accordance with Article [number] of [Amending Directive]. [(number)] The comments received during those consultations were published on a dedicated public website. [(number)] Evaluating the exemption application concluded that [main findings]. This evaluation included a technical and scientific assessment study.
Recital of the rationale for the exemption period or the adjustment period
[(number)] The requested exemption should be granted for [number] years from the date of application of this Directive. [(number)] It is appropriate to grant the exemption for an extensive validity period, in accordance with Article [number] of [Amending Directive]. It is appropriate to grant the exemption to be renewed, with a revised scope, for the maximum duration of [number] years until [dd Month yyyy]. This is necessary to provide compatible [equipment] for [services/ users] and to allow time to develop [general subject] alternatives. [(number)] In [yyyy], [Name of the Standard] published a revised version of standard [name of the standard]. This revised version has withdrawn the previous one. The previous version could be used during [period of time] until [Month yyyy]. [(number)] It is necessary to grant the exemption until [dd Month yyyy]. The reasons are:
a) the expected availability to substitute [substance] in the application depending on the exemption, and
b) possible future restrictions on [substance] in [general subject] in Regulation [yyyy/number]. [(number)] The exemption should expire, at the latest, on [dd Month yyyy]. By that time, the restriction entry [number] of Annex [number] to Regulation [yyyy/number] shall be reviewed. [(number)] The duration of the exemption is not expected to adversely impact innovation. This results from the ongoing efforts to find a reliable substitute. [(number)] The laws, regulations and administrative provisions necessary to comply with this Directive should apply at the latest for financial years beginning on or after [dd Month yyyy]. This is necessary to enable undertakings or groups to benefit from the adjusted thresholds as soon as possible.
Recital on the submission of the exemption application
[(number)] The requested exemption is consistent with Regulation [yyyy/number] of the European Parliament and of the Council. Thus, it does not weaken [the regulatory framework/standard]. [(number)] The exemption does not weaken [protection] given by Regulation [yyyy/number] of the European Parliament and of the Council. [(number)] It is currently not possible to substitute or otherwise eliminate [general subject] in the [component] with the same technical performance. Nor is this expected to be so in the foreseeable future. [(number)] Placing on the market for a use and the use of substances listed in Annex [number] to Regulation [yyyy/number] of the European Parliament and of the Council are to comply with authorisation requirement under that Regulation. [(number)] The total negative [impacts] of the substitute are expected to outweigh its total [benefits]. [(number)] Under Regulation [yyyy/number], management or investment companies are obliged to disclose how their due diligence policies take principal adverse impacts into account if:
a) they are obliged to consider principal adverse impacts of investment decisions on sustainability factors, or
b) they consider those principal adverse impacts voluntarily. [(number)] [Amending Directive] should reflect [obligation]. This is necessary to ensure consistency with Regulation [yyyy/number].
Recital of the findings and the implementation decision
[(number)] It is appropriate to grant the requested exemption. [(number)] The [factors] of [general subject] should be presented in a transparent manner. This enables the [entity] to provide the relevant information to potential clients. [(number)] The Commission considers it necessary to adjust and round up the thresholds referred to in Article [number] to [number] of [Amending Directive] by [number] % for inflation. [(number)] It is appropriate to grant the exemption to be renewed.
Recital of the formula to convey the concluding statement
[(number)] [Specific provisions within the directive] should therefore be amended accordingly,
Enacting formula
HAS ADOPTED THIS DIRECTIVE:
