I. Product Groups to Be Included Article 6 of Rohs

European Commission Norwegian Pollution Control Authority P.O.Box 8100 Dep, N-0032 Oslo, Rue de la Loi 200 Norway 1049 Brussels Visiting address: Strømsveien 96

BELGIUM Telephone: +47 22 57 34 00 Telefax: +47 22 67 67 06 E-mail: [email protected]

Date: 13 February 2008 Our ref.: 2003/1491 Your ref.: Contact person: Solvår Hardeng

Norwegian comments to the review of directive 2002/95/EC of the European Parliament and of the Council on the Restriction of the use of certain Hazardous Substances in Electrical and Electronic Equipment

Dear Sir or Madam,

The Norwegian Pollution Control Authority welcomes the opportunity to comment the different options and suggestions in this Stakeholder consultation. We have written our comments according to the text on internet.

I. PRODUCT GROUPS TO BE INCLUDED [ARTICLE 6 OF ROHS] Norway is still supporting the inclusion of both category 8 and 9 from 2012. There is a need for a clear timetable for all medical devices and monitoring and control instruments to avoid confusion for manufacturers and authorities. By this time (2012) the manufacturers will have gained a lot of experience in producing and using RoHS- compliant components and have also had time to redesign their products. In addition, many components will be available only as RoHS-compliant which often also will require redesign of the product.

There might be a need for some new exemptions, but the numbers and their wording need to be as stringent as possible. These future exemptions have to be adopted as soon as possible so that the industry knows the legislative requirements well in advance. This means they will have time to redesign their products accordingly. If there is a need to differentiate between In Vitro Diagnostics (IVD) and Active Implanted Medical Devices (AIMD) etc., this has to be done by an exemption which then must also include the possibility to be reviewed after some years. An implementation deadline of 2020 might give the manufactures the impression that there is no hurry and no need for changes before long. Due to this they might eventually start their development work too late and by that not meet the deadlines and they will then apply for new exemptions. Contrary would an exemption which has a date for review after some years give a clear signal that they have to start to develop RoHS-compliant products as soon as possible.

Organisation no.: 970 935 657 2 of 6

An important matter is that too many exemptions will imply a risk of confusion related to the enforcement and monitoring of the exemptions and related additional requests. It is also important to improve the environmental benefits of the directive by limiting the list of exemptions.

There is no need to differentiate between consumer/industrial equipment for cat. 9 because this will lead to confusion about the scope – see also III.

II. SUBSTANCES COVERED [ARTICLE 6 OF ROHS] Our experience is that the RoHS Directive is an effective legislation to manage risks to health and environment from the use of hazardous substances in EEE and it is important to maintain it as useful tool for addressing hazardous substances used in EEE. The RoHS Directive is well known by the majority of the manufacturers and importers of EEE.

This revision of RoHS is, according to our understanding, a much better opportunity for reducing risks to health and environment from the EEE than the REACH regulation - at least within the coming years. If the ongoing study by the Öko-Institutet should identify a need to include additional substances according to article 4.3 we believe that the RoHS will be a faster and more stringent track than REACH.

The reasons for this is that REACH only requires importers of articles to notify the presence of a Substance of Very High Concern (SVHC), if the substance is present in those articles in quantities above 1 tons per producer or importer per year and the substance is present in those articles with a concentration above 0,1% weight by weight.

According to the interpretation from the Commission, the concentration limit of 0,1 % in REACH is related to the whole article either it is simple (e.g. a resistor) or complex (e.g. a computer). Compared to the established maximum concentration limits in homogenous material within the RoHS directive, the REACH interpretation from the Commission will result in a much less stringent approach for hazardous substances in EEE if REACH is to be used.

New substances should be added for all categories of EEE in the scope of RoHS to avoid differences between sectors etc. and to avoid confusion about the scope of RoHS. There might be a need for time limited exemptions when introducing new substances, but these exemptions must be kept to a minimum.

Introduce labelling requirements We support that it might be beneficial to consider the possibility of including requirements on information and/or labelling of EEE which contains SVHC in the RoHS Directive. This measure would make information of the content of SVHC available to end users, e.g. consumers and public procurement buyers, so they are able to make a qualified purchase if they want. 3 of 6

III. TECHNICAL CHANGES TO THE SCOPE OF THE DIRECTIVE The Norwegian Pollution Control Authority supports to have a separate and complete RoHS scope. This will increase the completeness and autonomy of the text and increase transparency. By doing this it will be easier to include spare parts and components in a manner which is easily understandable and also is enforceable. This will increase the environmental benefit of the Directive and it would remove the uncertainties as to whether some equipment should be considered "part/component" or "final product". This would also more clearly spread the burden of compliance throughout the supply chain and it would facilitate information and compliance for final product manufacturers.

4. To insert in RoHS a clause similar to WEEE Art 2.3 (excluding equipment which is intended for specifically military purposes) would further clarify the scope of RoHS and remove ambiguity.

6. We think that it should be considered if it is relevant to use "finished product" as an example of part of another equipment if RoHS is separated clearly from the WEEE directive. It has proven very difficult to find a generally acceptable definition for avoiding abusive interpretations.

7. There is no need for maintaining a general exemption for LSIT (large-scale stationary industrial tools). An inclusive approach would enhance clarity and transparency. Maintaining the general exemption risks prolonging uncertainty and diverging interpretations. HS should be substituted whenever possible and it is a wrong signal to prolong the exclusion of equipment from RoHS requirements, if similar (in terms of composition or use) equipment is subject to substance restrictions;

8. We support extending the scope of RoHS to cover all EEE. This would enhance the environmental effect of the Directive and it would remove any uncertainty as to which equipment falls under the scope and therefore save a lot of time and effort. When extending the scope to all EEE, there will be a need for a transitional period where there will be e need for exemptions for some product types. In this period additional data should be collected to evaluate the impacts.

9. There is a need to review the wording of the Annex concerning the product categories as an indicative annex. The list in the annex should not be exhaustive, but the different product categories need to be laid out in a more stringent and comparable manner.

10. We would like to support the "Repair as produced" principle. Excluding parts for repairing and for the reuse of products lawfully placed on the market should be avoided, but unfortunately experience has shown that it is difficult to find a suitable legal text which also is enforceable. If it is possible to find such a legal text, it would enhance the legal clarity and security and it would be beneficial for the environment since it contributes to extending life time and avoiding untimely disposal of equipment. It would be a wider application of a principle already established in article 2.3 of RoHS. 4 of 6

IV. DEFINITIONS The RoHS directive is not a New Approach-directive and should not be a New Approach- directive in the future either. Still there might be a need to insert a definition for "placing on the market" to avoid diverging interpretations. The definition might be similar to the one in the REACH regulation.

6. We support to insert the definition for "homogeneous material" and the MCVs of the Commission decision. Adoption of this definition and of the MCVs would enhance clarity and legal certainty and facilitate implementation.

V. FACILITATING IMPLEMENTATION Va Enforcement of the RoHS Directive 1. The Informal Enforcement Bodies Network that already exists is supportive for the different MS enforcement bodies, but enforcement will always be a national issue.

2. Inclusion of a self declaration or third party verification might always be positive, but MS enforcement bodies must always have the possibility to challenge this.

3. To introduce marking to demonstrate RoHS compliance might be positive, but since the RoHS directive is not a New Approach-directive the use of CE marking in this respect should be avoided.

We support that there is a risk of confusion from proliferation of other not necessarily easily recognisable marks on a product. Since EEE are subject to mandatory labelling under the WEEE Directive this is a valid argument. Such confusion might be even greater if the marking is voluntary.

4. To exchange information about non-compliant products might be further elaborated. Preferably, no new system should be established, but the possibility to use existing notification systems, such as RAPEX should be explored.

5. We do not support to use standards as is foreseen in the New Approach. The basic argument is that the RoHS-directive already includes specific concentration limits for different substances. This is normally not included in a New Approach directive, but is normally defined in a appurtenant standard. It is possible that a future international standard might be developed on how a product should be tested to show RoHS-compliant, but not to secure that the requirement of the RoHS directive is fulfilled. Normally standards do not include any requirement concerning protection of human health and environment, but they often contain different safety measures. In addition it normally takes a long time to develop such standards.

Vb. Mechanism for exemptions It is important to speed up the exemption process, but at the same time is it important that is has been proven that the exemption is fulfilling the criteria in the directive. Experience has showed that a lot of applications for exemption have been rejected. A mechanism for 5 of 6

a quick “completeness check” should be included. This will secure “a fast track for refusal” of application of a low quality and time can be spent on going into solid and necessary applications.

Removal of the requirement for stakeholder consultation in article 5.2 of RoHS might be justified as long as it is replaced by other mandatory means of information collection. One important challenge is to secure useful information concerning possible alternatives and their availability. It is important to introduce that it is the industry and not the MS that should assume the burden of proof and the cost of quality-checking the application. A transparent system for how many applications has been received by the Commission and their status should be created to inform both industry and MS.

In the future the Norwegian authority thinks it is important to support a very restrictive attitude towards exemptions for existing products. In this way we will support innovation in the design phase of new products.

All future exemptions should include a specific date of expiration or review. This is important to give a clear signal to industry that the exemptions are not given for ever.

5. We support that the manufacturers have to provide substitution plan when requesting for an exemption. It would enhance the environmental effect of the Directive and increase certainty by clearly signalling that exemptions should only be seen as a temporary measure and that the objective is being substitution. It would encourage stakeholders to establish clear roadmaps towards a substitution. Similar requirements exist under REACH and to integrating them in RoHS would increase coherence and equal treatment and should not incur any additional costs in the medium term.

6. It would be useful to establish a standard format for providing information on requested exemptions. This would be helpful for simplifying and speeding up the decision-making process in the Regulatory Committee (TAC), which has welcomed the principle in the past. A mandate to elaborate such a standard format could be given by the Directive to the Regulatory Committee.

7. We do not support to introduce cost criteria for granting exemptions. To change and possibly reduce the requirement for exemptions two years after the date for entry into force will give a very unfortunate signal concerning the importance of the directive to contribute to the protection of human health and the environment. Especially to all the companies which have invested huge amounts of money into being RoHS-compliant from the entry into force of the directive two years back. This will also be a step back for the human health and environment. To include socio-economic criteria might also be a very difficult discussion and burdensome additional step which might take additional time. We risk that such a step will slow down the exemption process considerably.

9. We do not support that exemption requests should be submitted directly to the TAC. There need to be system managed by the Commission or some they nominate (e.g. a scientific/technical consultant) which receives the applications and starts the procedure 6 of 6

with the “completeness-, quality- and alternative-check” before sending the documents to the Commission and afterwards to TAC. If not there is a risk of disproportionate attention and time consumption of the TAC for handling the exemptions which might detriment other implementation issues of RoHS.

We hope that our comments will be helpful for the Commission in your further work with the review of this important directive. We relay that we have a common interest in that this directive should continue to contribute to protection of human health and the environment. Please do not hesitate to contact us for clarification of the above or for further possible input.

Yours sincerely

Berit E. Gjerstad Solvår Hardeng Head of Section Special Adviser