Learn what basic acts, amendments, corrigenda and consolidated texts are, which documents are legally binding and how to record the legislative version used in a traceable way.
Basic acts, amendments and corrigenda
The basic act is the original directive or regulation as first published in the Official Journal of the European Union. It has its own number, publication date and provisions governing entry into force and application.
An amendment is a separate legal act that identifies exactly which articles, annexes or other passages of the basic act are inserted, replaced or deleted. It has its own official publication and may specify a separate date of entry into force or application.
A corrigendum is an official correction of errors in a published text, such as an incorrect reference, numbering or translation. It does not introduce new policy choices in the same way as an amendment, but corrects how the adopted text was published.
The basic act does not disappear after an amendment or corrigendum. To determine the current obligations, it must be read together with every amendment and correction applicable on the relevant date. Wording that has been legally replaced does not remain a separate current obligation.
What is a consolidated version?
EUR-Lex combines a basic act, later amendments and corrigenda into one readable consolidated text. It shows how the legislation reads at a particular point in time. The date in its header refers to the date on which the latest included amendment becomes applicable.
EUR-Lex markers indicate the source of the text: B denotes the basic act, M an amending act and C a corrigendum. These markers allow readers to trace the combined wording back to its individual source acts.
Which documents are legally binding?
EUR-Lex states that a consolidated text is a documentation tool only and has no legal effect. The authentic texts are the basic act and its amending and correcting acts as published in the Official Journal of the European Union.
Use a consolidated version for efficient reading and searching, but check the underlying authentic publications for legal interpretation, uncertainty or a significant change. Since 1 July 2013, the electronic edition of the Official Journal on EUR-Lex is generally authentic and produces legal effects.
How to check the current version on EUR-Lex
Open the basic act on EUR-Lex and check its document information, current status and any link to a consolidated text. Then review the list of acts that amend or correct it and note the application date of each change.
Determine whether the latest amendment applies when the product is placed on the market. A recently published amendment may have a later application date, and a consolidated text may not yet include a very recent publication.
Verify the number, title and ELI or CELEX reference of the basic act
Review amending acts, corrigenda and their application dates
Record the date of the consolidated version used
Verify important provisions in the authentic publications
Repeat the check when the design, market date or legislation changes
Version control in technical documentation
Technical documentation should make clear which legal requirements informed design and conformity assessment. Record not only the directive or regulation number, but also the relevant reference date, amendments and transitional provisions.
If legislation changes during a project, assess the consequences for the design, essential requirements, standards, tests, instructions and declaration. Keep the rationale for that assessment with the dossier.
How DME-CE handles this
DME-CE checks official sources daily for new amendments and other changes to supported directives and regulations. A detected change can therefore be assessed before the relevant legal content in the legislation library is updated.
Applicable legislation, essential requirements, decisions and evidence remain connected within a product or project. This makes clear not only what must be demonstrated, but also which legal framework supports the assessment and how a change may affect documentation in progress.
Automated monitoring does not replace the manufacturer’s responsibility. For important legal decisions, check the authentic publication and seek specialist advice where the effect or transition of a change is uncertain.