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Battery Testing
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TRAINING
EU Legal Explanation (II)
Author.
LCS
Source:
Post time:
2024-10-14
Types of EU legal acts
EU treaties
The treaty sets out the objectives of the European Union, the rules of EU institutions, decision-making methods, and the relationship between the EU and its member states. The EU treaties are periodically revised to reform EU institutions and give them new areas of responsibility. They have also been revised to allow new EU countries to join the EU.
These treaties are negotiated and agreed upon by all EU countries, then approved by their parliaments, and sometimes subject to a national referendum.
Regulations
Regulation is a legal act that automatically applies uniformly to all EU countries once it comes into effect, without the need to translate it into national law. They are binding on all EU countries.
Note 1: For example, EU REACH: Regulation (EC) No 1907/2006; EU CLP: Regulation (EC) No 1272/2008; EU POPs: Regulation (EU) 2019/1021, etc., are EU level legislation and directly apply to all member states.
Note 2: Electronic cigarette liquids need to meet CLP requirements in the European Union due to their toxicity risks. So the Poison Center Notification (PCN), including the Unique Formula Identifier (UFI), is a unified requirement at the EU level that all member states need to implement uniformly, as well as tactile warning labels.
Note 3: Legislation, judiciary, and law enforcement are integrated into one entity. However, in fact, based on various objective factors, legislation often lags behind market development, while law enforcement is cyclical and to some extent weaker than legislative requirements. On the one hand, the judiciary obtains market feedback from law enforcement, and on the other hand, the results of the judiciary are also one of the sources of legislation.
Instructions
The directive requires EU countries to achieve certain results, but allows them to freely choose how to achieve them. EU countries must take measures to incorporate it into national law (transpose instead of cover, in other words, not change its content. Taking TPD as an example, member state transposed regulations cannot conflict with TPD in any way) in order to achieve the goals set by the directive. National authorities must inform the European Commission of these measures.
The directive must be translated into national law within the deadline specified at the time of its adoption (usually within 2 years). If a country does not translate the directive into national law, the Commission may initiate infringement proceedings (i.e., under EU treaties, the Commission may take legal action against EU countries that do not comply with EU law).
Note 1: Regarding the requirements related to electronic cigarettes, some member states of the EU TPD must implement them uniformly. For example, nicotine concentration of 20mg/mL, 2mL of smoke cartridges used in conjunction with devices, 10mL of oil bottles, etc., these requirements are unified within the European Union. However, the TPD does not specify certain aspects, such as taxes, notification fees, and the nature of penalties, which each member state can decide on its own and only take effect within its own country. Due to the fact that the UK has already left the EU, it has obtained independent interpretation rights for TRPR and does not necessarily require consistency with TPD. This is also the reason why 2+10 has been relatively hot in the UK market recently but has repeatedly encountered obstacles in the EU
Note 2: Although the UK has already left the EU and gained independent interpretation power. But it is a fact that TRPR originated from TPD, and many of its terms are still in line. The author believes that the rationality of 2+10 is questionable both in terms of regulatory provisions and legislative purposes. Moreover, because the implementation and supervision of TRPR in the UK are the result of the joint efforts of multiple departments, MHRA only has the authority to review the content of notices, which is only a part of product compliance content.
So declaring qualified does not mean that the product is completely qualified, and MHRA does not endorse product safety.
Decisions made
Decision is a binding legal act that can be universally applicable or have specific objects.
Decisions can be legislative bills or non legislative bills.
The resolution passed jointly by the following persons shall be a legislative act:
• Submit to the European Parliament and the Council through the ordinary legislative process, or
The European Parliament, with the participation of the Council, or
According to the special legislative procedure, with the participation of the European Parliament and the European Council
Resolutions are usually non legislative acts, generally but not exclusively taken by the European Commission based on authorization (delegated acts) or the implementation of legislation (implementation plans).
Suggested Recommendations
The suggestion is not binding. Suggest allowing EU institutions to express their views and propose action plans, but without imposing any legal obligations on the recipients. Although recommendations do not have legal consequences, they may provide guidance for the interpretation or content of EU law.
Opinions
Opinions are not binding. Opinion "is a means for EU institutions to issue statements, but does not impose any legal obligations on the subject of the opinion.
Note 1: Although suggestions and opinions do not have legal binding force. But it is often adopted to promote the development of matters in the direction expected by the "official".
Delegated Acts
The authorization bill is a legally binding act. But authorization bills are generally non legislative bills passed by the European Commission, used to modify or supplement non essential elements in legislation.
The power of the committee to pass authorization bills is subject to strict conditions:
The basic act must specify the purpose, content, scope, and duration of authorization (such as specifying which parts of the toy directive can be modified, etc.);
The actual authorization bill passed based on this authorization cannot change the basic content of the basic bill (i.e. the main content committee does not have the ability to modify it independently, and if necessary, it still needs to be discussed or approved by the European Parliament and the Council of the European Union);
The authorization bill can only have universal applicability (i.e. cannot solve individual situations).
The committee will consult experts from EU member states before passing the authorization bill. In addition, the European Parliament or the Council of the European Union may revoke the authorization of the Commission, and if the Parliament and the Council have objections to modifications or supplements, they may also initiate inquiries in accordance with the procedure. In addition, the authorization bill passed by the committee can only take effect within the time limit specified in the basic bill, usually 2 months, and without objection from the council or parliament.
Authorization bills are usually used when legislative bills (including their annexes) must be periodically adjusted to take into account technological and scientific progress.
Implementing Acts
The implementation bill is a legally binding bill, but it is also a non legislative bill that can be applied separately or universally. It enables the committee to establish conditions under the supervision of a committee composed of representatives from EU countries, ensuring the uniform application of EU law.
Note 1: For example, in order to promote the implementation of TPD electronic cigarette related provisions, the committee has passed two implementation bills
General format for electronic cigarettes and supplementary containers notification issued by Commission Implementing Decision (EU) 2015/2183
Commission Implementing Decision (EU) 2016/586 released technical standards for electronic cigarette filling mechanisms
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