CE MARKING, REACH AND RoHS

Product Compliance Pack for EU Market Access

This document provides a practical compliance reference and template declaration for Indian exporters and EU importers dealing with products that must meet CE marking, REACH, and RoHS requirements before they can be placed on the EU market. It includes guidance on scope, obligations, technical file requirements, and ready-to-use declaration templates.

PART 1 — CE MARKING

1.1 What Is CE Marking?

CE marking is a mandatory conformity marking for products within the scope of specific EU harmonisation legislation (EU Directives and Regulations). It indicates that the manufacturer or their authorised representative has assessed the product against the applicable EU essential requirements and is declaring that the product conforms to those requirements.

CE marking is not a quality mark or a certification by a third party in most cases. For low-risk products (e.g. general machinery, simple electrical equipment), the manufacturer self-declares conformity and affixes the CE mark. For higher-risk products (e.g. medical devices, lifts, pressure equipment), a Notified Body must be involved in the conformity assessment.

1.2 Which Products Require CE Marking?

Products covered by EU CE marking legislation include, but are not limited to:

This list is not exhaustive. Always verify whether your specific product falls within the scope of one or more CE marking Directives or Regulations by checking the European Commission's list of harmonisation legislation.

1.3 Steps to Achieve CE Marking Compliance

Identify applicable EU Directives and Regulations for your product category and HS code.

Identify the applicable essential requirements in each applicable Directive / Regulation — these are the mandatory technical and safety requirements the product must meet.

Identify whether a Notified Body is required (for products in higher-risk categories) or whether self-declaration of conformity is sufficient.

Conduct conformity assessment — either internally (for self-declaration) or with a Notified Body. This involves testing the product against applicable harmonised standards (EN standards), which provide a presumption of conformity when followed.

Compile the Technical File — the set of documents that demonstrates how the product meets the essential requirements (see section 1.4 below).

Draw up the EU Declaration of Conformity (DoC) — a formal written statement signed by the manufacturer or authorised representative declaring the product's conformity.

Affix the CE mark to the product or its packaging. The CE mark must meet the minimum size requirements (minimum 5mm height) and be visible, legible, and indelible.

For products requiring Notified Body involvement, include the Notified Body number after the CE mark.

1.4 Technical File Requirements

The Technical File must be retained by the manufacturer or EU Responsible Person for at least 10 years after the last date of manufacture of the product. It must include:

A general description of the product and its intended use.

Design and manufacturing drawings and schematics.

List of applicable EU Directives / Regulations and harmonised standards applied.

Test reports demonstrating conformity with applicable harmonised standards or essential requirements.

Risk assessment documentation.

Results of calculations and examinations carried out.

Description of technical solutions adopted to meet the essential requirements where harmonised standards were not fully applied.

EU Declaration of Conformity (copy).

Notified Body certificate (if applicable).

1.5 EU Declaration of Conformity Template

PART 2 — REACH COMPLIANCE

2.1 What Is REACH?

REACH — Registration, Evaluation, Authorisation and Restriction of Chemicals — is Regulation (EC) No 1907/2006 of the European Parliament and of the Council. It is the EU's primary chemicals regulation and applies to substances on their own, in mixtures, and in articles (manufactured products that contain chemicals).

2.2 REACH Obligations for Indian Exporters

Indian exporters are not directly subject to REACH — REACH obligations fall on EU importers and EU-based manufacturers. However, Indian exporters have important indirect obligations because their EU buyers will require REACH compliance information to fulfil their own legal obligations:

SVHC (Substances of Very High Concern) in Articles: If your product (article) contains a Substance of Very High Concern on the EU Candidate List at a concentration above 0.1% by weight, the EU importer must: notify ECHA (European Chemicals Agency) if importing more than 1 tonne per year; and provide information to customers and consumers on request within 45 days.

Safety Data Sheet (SDS): For chemical substances and mixtures supplied to EU buyers, a REACH-compliant SDS in the language of the EU member state of import must be provided.

Substance Registration: Substances imported into the EU in quantities of 1 tonne or more per year must be registered with ECHA by the EU importer or their Only Representative (OR). Indian exporters supplying large volumes may need to appoint an Only Representative in the EU to handle REACH registration on their behalf.

Restrictions: Certain substances are restricted under REACH Annex XVII — products containing restricted substances above permitted concentration limits cannot be placed on the EU market regardless of origin.

Authorisation: Some substances require authorisation under REACH Annex XIV before they can be used for specific purposes in the EU.

2.3 REACH Compliance Declaration Template

PART 3 — RoHS COMPLIANCE

3.1 What Is RoHS?

RoHS — Restriction of Hazardous Substances — is Directive 2011/65/EU (RoHS 2) as amended by Directive (EU) 2015/863 (RoHS 3). It restricts the use of ten hazardous substances in electrical and electronic equipment (EEE) placed on the EU market.

3.2 Restricted Substances under RoHS

RoHS compliance is a prerequisite for CE marking of EEE. EEE placed on the EU market must include a RoHS compliance declaration or a combined CE/RoHS Declaration of Conformity.

3.3 RoHS Compliance Declaration Template

Doc 37 — CE Marking, REACH and RoHS Product Compliance Pack — Neutral Template