Brussels, 14 September 2022

布鲁塞尔，2022年9月14日

grow.d.3(2022)7036064

NOTE FOR THE ATTENTION OF MARKET SURVEILLANCE AUTHORITIES AND NOTIFYING AUTHORITIES致市场监督机构和公告机构的备忘

        Subject:Voluntary certification for products subject of EU technical  harmonisation legislation

        主题：欧盟技术协调立法下产品的自愿认证

Some market surveillance authorities have brought to the attention of the Commission and other authorities that a practice of ‘voluntary certification’ exists for some products, which are subject of EU technical harmonisation legislation (namely for PPE, Medical Devices, ATEX, RED and PED), especially during the COVID-19 crisis. However, later the application of this practice has been noticed for a number of other harmonised products, including very dangerous products (such as machines used in explosive environments, civil explosives or pyrotechnic articles) for which participation of a notified body in the conformity assessment is always necessary.

一些市场监督机构向委员会及其他相关机构报告，某些欧盟技术协调立法适用的产品（如个人防护设备（PPE）、医疗器械、ATEX、无线电设备指令（RED）和压力设备指令（PED））存在“自愿认证”的现象，尤其是在COVID-19危机期间。然而，随后发现这种做法也适用于其他协调产品，包括非常危险的产品（如用于爆炸性环境的机器、民用爆炸物或烟火制品），这些产品需要公告机构在合格评定中参与。

While the websites for such ‘voluntary certification’ usually indicate that this activity is not performed in the capacity of the certification body as notified body as such, and it is usually presented as something similar to a ‘quality marking’, the notified body number has been used in some cases on such documents (whereas the body is not notified for the products in question), these documents are called certificates, and very often the CE marking is present on these documents issued1. This is not compatible with the Union product legislation as detailed below, as such a practice leads to confusion and misunderstandings on the effective value of such documents, including also uncertainties about the effective safety and compliance of the concerned products.

尽管这些“自愿认证”的网站通常表明该活动并非由认证机构作为公告机构执行，且通常被描述为类似“质量标志”，但在某些情况下，这些文件上使用了公告机构编号（尽管该机构未被公告为相关产品提供服务）。这些文件被称为“证书”，且通常带有CE标志。然 而，这种做法与欧盟产品立法不符，如下所述，因为它会导致对这些文件的实际价值产生混淆和误解，包括对相关产品的实际安全性和合规性的不确定性。

It is also to be noted that the terms certification, independent third party and similar have a specific meaning as it comes to harmonised Union product legislation, essentially related to the work carried out by notified bodies in their capacity and according to the relevant conformity assessment procedure(s), and their use for other types of assessments of products falling under this legislation may be misleading. Certificate is a document issued by a body that takes responsibilities in areas of public interest. Therefore, if a Union product legislation does not provide for a third-party involvement in the conformity assessment but the economic operator opts for a voluntary involvement of a third party, the document issued by that third party could bear the name ‘certificate’ only if the body involved on a voluntary basis is a notified body for the specific area. A notified body may carry out activities in areas where it is not notified (for example, in non-harmonised areas or when products are intended for third countries); but it has to clearly mention that these activities are not in the scope of their notification under harmonised Union product legislation, as notified by the competent authorities and listed in the Commission’s NANDO information system and these activities cannot be in an area of harmonised Union product legislation which requires assessment by a notified body. The notified body cannot use its notified body number in relation to assessments, tests, certificates or other activities for the legislation it is not notified for. The non- notified activities may not overlap with the notified ones, they must be clearly distinguished from the notified ones, they may not create confusion and they must be clearly mentioned as “non-notified”; otherwise the notifying authority must take appropriate action.

需要注意的是，在欧盟协调立法中，“认证”、“独立第三方”等术语有特定含义，主要与公告机构依据相关合格评定程序开展的工作相关。这些术语用于描述落入该立法范围内的其他类型产品评估时可能会产生误导。“证书”是由在公共利益领域负责的机构出具的文件。因此，如果欧盟产品立法不要求第三方参与合格评定，但经济运营者选择自愿引入第三方，则仅当该第三方是特定领域的公告机构时，才能将该文件称为“证书”。
公告机构可以在非公告领域（如非协调领域或针对第三国的产品）开展活动；但必须明确表明这些活动不属于其在协调欧盟产品立法下的公告范围，这些活动不得涉及要求公告机构评估的协调欧盟产品立法领域。此外，公告机构不得在其未被公告的立法领域使用公告编号。这些非公告活动不得与公告活动重叠，必须与公告活动明确区分开来，并且必须明确标注为“非公告”行为；否则，公告机构管理机构必须采取适当措施。

The notified body must have policies and procedures that distinguish between the tasks it carries out as a notified body and any other activity in which it is engaged, and it must make this distinction clear to its customers. Accordingly, marketing material must not give any impression that assessment or other activities carried out by the body are linked with tasks described in the applicable Union harmonisation legislation. Also to be emphasized that CE marking is only to be affixed after testing the product and performing the prescribed conformity assessment procedure or procedures according to the applicable Union harmonisation legislation. For some product legislation2 and for medium-high risk products3, involvement of a notified body is mandatory – the manufacturer cannot perform the assessment alone, nor use of a non-notified conformity assessment body is enough either to issue the EC/EU declaration of conformity or to affix the CE marking.

公告机构必须拥有政策和程序，将其作为公告机构执行的任务与参与的其他活动区分开，并向客户清楚说明这一区分。此外，其营销材料不得暗示其开展的评估或其他活动与欧盟协调立法中的任务相关。还应强调，CE标志仅能在根据适用的欧盟协调立法进行产品测试并完成规定的合格评定程序后方可粘贴。
对于某些产品立法以及中高风险产品，公告机构的参与是强制性的——制造商不能单独完成评估，也不能仅凭非公告合格评定机构出具的文件发布欧盟符合性声明或粘贴CE标志。

Article 30(2) of Regulation (EC) No 765/2008 states that the CE marking <...> shall be affixed only to products to which its affixing is provided for by specific Community harmonisation legislation, and shall not be affixed to any other product. Article R12(1) of Decision 2008/768/EC, which is integrated in most of the pieces of sectoral legislation4, foresees a possibility to affix the CE marking to the packaging or the accompanying documents only if fixing it to the product or its data plate is not possible and if the product legislation provides for such documents. Therefore, it is not acceptable for such ‘voluntary certificates’ to bear a CE marking.

第765/2008号条例第30(2)条规定，CE标志只能粘贴在相关欧盟协调立法规定的产品上，且不得粘贴在任何其他产品上。第2008/768/EC决定R12(1)条（已纳入大多数部门立法中）规定，仅当无法将CE标志粘贴在产品或其铭牌上时，且产品立法规定了此类文件的情况下，方可将CE标志粘贴在包装或随附文件上。因此，带有CE标志的“自愿证书”是不可接受的。

Article 30(5) of Regulation (EC) No 765/2008 states that the affixing to a product of markings, signs or inscriptions, which are likely to mislead third parties regarding the meaning or form of the CE marking, shall be prohibited. Clearly, this is the case for ‘voluntary certificates’ bearing CE marking. Such a ‘certificate’ leads to understanding that the product is in conformity with applicable Union legislation, however the ‘voluntary certificate’ is issued without any product checks and is not foreseen in any of the legislation. As stated on the concerned websites, it is usually issued following documentation checks only.

第765/2008号条例第30(5)条规定，禁止在产品上粘贴可能误导第三方关于CE标志意义或形式的标记、符号或说明。这显然适用于带有CE标志的“自愿证书”。这种“证书”会让人认为产品符合适用的欧盟立法，但实际上这些“自愿证书”未经任何产品检查，也不在任何立法范围内。相关网站显示，此类证书通常仅基于文件检查。

Article 30(6) of Regulation (EC) No 765/2008 obliges Member States to take appropriate action in the event of improper use of the marking. Member States shall also provide for penalties for infringements, which may include criminal sanctions for serious infringements.

第765/2008号条例第30(6)条要求成员国在标志使用不当时采取适当行动，并对违规行为设置处罚措施，包括严重违规的刑事处罚。

Article R34(1)(a) of Decision 2008/768/EC, which is integrated in most of the pieces of sectoral legislation, requires that where a Member State finds that the conformity marking has been affixed in violation of Article [R11] or of Article [R12], it shall require the relevant economic operator to put an end to the non-compliance concerned. Article R34(2) further requires that where such the non-compliance persists, the Member State concerned shall take all appropriate measures to restrict or prohibit the product being made available on the market or ensure that it is recalled or withdrawn from the market.

第2008/768/EC决定R34(1)(a)条（已纳入大多数部门立法）要求，若成员国发现符合性标志违反[R11]或[R12]条规定，则应要求相关经济运营者纠正不合规行为。第R34(2)条进一步要求，若不合规行为持续存在，相关成员国应采取一切适当措施，限制或禁止产品进入市场，或确保产品被召回或从市场中撤出。

Taking into account the above:

行动建议

(1) Market surveillance authorities are requested to take notice of the aboveand check their respective markets for products, which bear incorrect documentation and, subsequently, take appropriate action. Special attention  is to be paid to conformity assessment of products. All products  falling under harmonised Union product legislation for which conformityassessment procedures foreseen in the respective legislation have not been  followed, shall be taken off the market and this shall be considered as a serious infringement by the economic operator. 市场监督机构应注意上述内容，并检查其市场是否存在文档不正确的产品，并采取适当行动。应特别关注产品合格评定。对于未按相关立法规定的合格评定程序操作的协调产品，应将其下架，并将此视为经济运营者的严重违规行为。

(2)   Notifying/designating authorities are requested to also take notice of the above and make sure that the bodies they have notified ordesignated are not performing any misleading activities using their notification, also that they use their notified body number properly and  only for the sectors they are notified for. The activities outside the scope of technical harmonisation legislation of the notified bodies should not compromise or diminish confidence in their competence, objectivity, impartiality or operational integrity. Where the notification is misused, a withdrawal of notification shall be considered. 公告/指定机构需确保其公告或指定的机构未利用公告开展误导性活动，并正确使用公告编号。公告机构在协调技术立法范围之外的活动不应削弱对其能力、客观性、公正性或运营完整性的信心。如发现公告被滥用，应考虑撤销公告。

Commission reserves the right to also take any necessary action to challenge the competence of notified bodies involved in such practices, or to withdraw their notification by using the specific provisions laid down in EU harmonisation legislation5. 委员会保留根据欧盟协调立法相关条款（如第2016/425号条例第31条和第2017/745号条例第47条）采取必要措施，质疑相关公告机构的能力或撤销其公告的权利。 

1 TheEuropean Safety Federation (ESF), which groups national associations of manufacturers, importers anddistributors of Personal Protective Equipment in Europe prepared a list of such certificates and published it on itswebsite:https://www.eu-esf.org/covid-19/4513-covid-19-suspicious-certificates-for-ppe 

2 Directive 2013/29/EU on pyrotechnic articles, Directive 2014/28/EU on civil explosives

3 Regulation (EU) 2016/425 on personal protective equipment, Regulation (EU) 2017/745 on medical devices, Regulation (EU) 2017/746 on in vitro diagnostic medical devices Directive 2013/29/EU on pyrotechnic articles, Directive 2014/28/EU on civil explosives; under Directive 2014/53/EU on radio equipment, it is mandatory for certain requirements, if relevant harmonised standards do not exist or are not applied.

4 Article 20(41)of Directive 2013/29/EU, Article 23(1)of Directive 2014/28/EU,Article 19(1)of Directive 2014/53/EU (CE marking on the packaging is always mandatory) 

5 For instance, Article 31 of Regulation (EU) 2016/425 on personal protective equipment, Article47 of Regulation (EU) 2017/745 on medical devices, etc.

(e-signed)

Matthias SCHMIDT‑GERDTS Head of Unit

电子签名于2022年9月14日 11:17 (UTC+02)

Commission européenne/Europese Commissie, 1049 Bruxelles/Brussel, BELGIQUE/BELGIË - Tel. +32 22991111 Office: N105 04/044 - Tel. direct line +32 229-81579

                                 Lina.KARBAUSKAITE@ec.europa.eu

Electronically signed on 14/09/2022 11:17 (UTC+02) in accordance with Article 11 of Commission Decision (EU) 2021/2121