+----+------------------------+---------+------------------------+----+
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|    | height="0.86875in"}    |         |                        |    |
+----+------------------------+---------+------------------------+----+
| C  |                        |         | Brussels, 4 December   |    |
| OU |                        |         | 2006                   |    |
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| HE |                        |         |                        |    |
| EU |                        |         |                        |    |
| RO |                        |         |                        |    |
| PE |                        |         |                        |    |
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| ON |                        |         |                        |    |
+----+------------------------+---------+------------------------+----+
|    | Interinstitutional     |         | 16216/06               |    |
|    | File:                  |         |                        |    |
|    |                        |         | LIMITE                 |    |
|    | 2003/0256 (COD)        |         |                        |    |
|    |                        |         |                        |    |
|    | 2003/0257 (COD)        |         |                        |    |
+----+------------------------+---------+------------------------+----+
|    |                        |         | COMPET 377             |    |
|    |                        |         |                        |    |
|    |                        |         | ENV 672                |    |
|    |                        |         |                        |    |
|    |                        |         | CHIMIE 39              |    |
|    |                        |         |                        |    |
|    |                        |         | CODEC 1465             |    |
+----+------------------------+---------+------------------------+----+

NOTE

+-----------+----------------------------------------------------------+
| from :    | Presidency/General Secretariat                           |
+-----------+----------------------------------------------------------+
| to :      | Permanent Representatives Committee (Part 1)             |
+-----------+----------------------------------------------------------+
| No. prev. | 13832/06 COMPET 269 ENV 525 CHIMIE 30 CODEC 1080         |
| doc. :    |                                                          |
+-----------+----------------------------------------------------------+
| No. Cion  | 15409/03 COMPET 75 ENV 651 CHIMIE 3 CODEC 1692 ADD 1 +   |
| prop. :   | ADD 2 + ADD 3 + ADD 4 + ADD 5 +ADD 6                     |
+-----------+----------------------------------------------------------+
| Subject : | Proposal for a Regulation of the European Parliament and |
|           | of the Council concerning the Registration, Evaluation,  |
|           | Authorisation and Restriction of Chemicals (REACH),      |
|           | establishing a European Chemicals Agency and amending    |
|           | Directive 1999/45/EC and Regulation (EC) {on Persistent  |
|           | Organic Pollutants}\                                     |
|           | \                                                        |
|           | Proposal for a Directive of the European Parliament and  |
|           | of the Council amending Council Directive 67/548/EEC in  |
|           | order to adapt it to Regulation (EC) of the European     |
|           | Parliament and of the Council concerning the             |
|           | registration, evaluation, authorisation and restriction  |
|           | of chemicals                                             |
|           |                                                          |
|           | \- Information from the Presidency on the outcome of the |
|           | 6th trilogue, 30 November 2006,                          |
|           |                                                          |
|           | \- Analysis of the compromise text with a view to        |
|           | agreement                                                |
+-----------+----------------------------------------------------------+

Following preparation in the Permanent Representatives Committee, [the
Presidency]{.underline} has met in informal trilogues with
representatives of the European Parliament and the Commission on six
occasions since late September 2006. The aim of these trilogues was to
reach a compromise between the Council and the European Parliament on
amendments to the Council\'s Common Position on REACH with a view to an
agreement at second reading.

At the sixth trilogue on 30 November 2006, the three Institutions
agreed, *ad referendum*, on the package of amendments examined during
the trilogues. As compared to the package discussed in Coreper on 29
November, attention is drawn to the following points, which were the
subject of the long discussions at the trilogue:

\- [communication of information]{.underline} - Article 3.25 regarding
\"identified use\" stays as in the Common Position;

\- [registration/data sharing]{.underline} (Annex VIII Section 8.7)- the
Commission shall review the methods for testing of reproductive toxicity
12 years after the entry into force of REACH;

\- [authorisation/substitution]{.underline} - authorisation of PBT and
vPvB substances are excluded from the \"adequate control route\". Six
years after the entry into force of REACH, the Commission shall review
whether the same shall apply to substances with endocrine disrupting
properties;

\- [electronic public access to information]{.underline} (Article 118) -
the name in the IUPAC Nomenclature for non-phase-in substances which are
dangerous within the meaning of the Directive 67/548/EEC may be kept
confidential for a period of six years (protection of intellectual
property rights).

The package of amendments is set out in Annex A to this Note. The
amendments are presented subject by subject in line with the structure
of previous documents.

**[The Committee]{.underline} is invited to**

**- agree to the package of amendments to the Common Position set out in
Annex A;**

**- mandate the Chair of the Committee to inform Parliament that the
Council is in a position to accept these amendments with a view to a
second reading agreement;**

**- take note of the Commission Statements set out in Annexes B and C.**

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

The three Institutions have agreed that a second reading agreement
should be based on a so-called \"package approach\" covering the
following issues:

1.  Duty of care/international obligations

2.  Animal welfare

3.  Communication of information

4.  Comitology

5.  Agency

6.  Registration/Data sharing

7.  Authorisation, including substitution

8.  Other issues

    **1. DUTY OF CARE/INTERNATIONAL OBLIGATIONS**

+-----------------------+-----------------------+----------------------+
| **Council Common      | **EP amendment**      | **Result of the 6th  |
| Position**            |                       | trilogue**           |
+-----------------------+-----------------------+----------------------+
| Recital 4 a           | Amendment 2           | The trade aspects    |
|                       |                       | are strengthened by  |
| Does not exist.       | ***(4a) REACH should  | rewording recital    |
|                       | be so designed and    | (3) as follows:      |
|                       | applied as to avoid   |                      |
|                       | weakening the         | \(3\) A high level   |
|                       | competitiveness of    | of human health and  |
|                       | European trade and    | environmental        |
|                       | industry or damaging  | protection should be |
|                       | trade with third      | ensured in the       |
|                       | countries. The        | approximation of     |
|                       | Regulation must not   | legislation on       |
|                       | impose any            | substances, with the |
|                       | requirements on the   | goal of achieving    |
|                       | European Union\'s     | sustainable          |
|                       | trading partners      | development. That    |
|                       | other than such as    | legislation should   |
|                       | would be compatible   | be applied in a      |
|                       | with the free-trade   | non-discriminatory   |
|                       | principles in force   | manner whether       |
|                       | under WTO             | substances are       |
|                       | provisions.***        | traded on the        |
|                       |                       | internal market or   |
|                       |                       | internationally      |
|                       |                       | ***in accordance     |
|                       |                       | with the             |
|                       |                       | Community\'s         |
|                       |                       | international        |
|                       |                       | commitments***.      |
+-----------------------+-----------------------+----------------------+
| Recital 14            | Amendment 7           | A new recital with a |
|                       |                       | view to explaining   |
| \(14\) Responsibility | \(14\) Responsibility | that the duty of     |
| for the management of | for the management    | care is effectively  |
| the risks of          | of***,*** ***and      | covered by           |
| substances should lie | provision of          | fulfilling the       |
| with the ***natural   | information***        | duties of this and   |
| or legal persons***   | ***on,*** the risks   | other associated     |
| that manufacture,     | of substances should  | legislation is       |
| import, place on the  | lie with the          | added.               |
| market or use these   | ***enterprises***     |                      |
| substances.           | that manufacture,     |                      |
| Information on the    | import, place on the  |                      |
| implementation of     | market or use these   |                      |
| this Regulation       | substances.           |                      |
| should be easily      | Information on the    |                      |
| accessible, ***in     | implementation of     |                      |
| particular*** for     | this Regulation       |                      |
| ***SMEs***.           | should be easily      |                      |
|                       | accessible,           |                      |
|                       | ***particularly***    |                      |
|                       | for ***very small***  |                      |
|                       | ***businesses, which  |                      |
|                       | should not be         |                      |
|                       | disproportionately    |                      |
|                       | penalised by the      |                      |
|                       | implementation        |                      |
|                       | procedures.***        |                      |
+-----------------------+-----------------------+----------------------+
| Article 1.1           | Amendment 26          | The trade aspect is  |
|                       |                       | covered by recital   |
| 1\. The purpose of    | 1\. The purpose of    | (3).                 |
| this Regulation is to | this Regulation is to |                      |
| ensure a high level   | ensure a high level   | \(3\) A high level   |
| of protection of      | of protection of      | of human health and  |
| human health and the  | human health and the  | environmental        |
| environment ***as     | environment, the free | protection should be |
| well as*** the free   | circulation of        | ensured in the       |
| circulation of        | substances on the     | approximation of     |
| substances on the     | internal market***,   | legislation on       |
| internal market while | increased             | substances, with the |
| enhancing             | transparency and the  | goal of achieving    |
| competitiveness and   | promotion of          | sustainable          |
| innovation.           | non-animal            | development. That    |
|                       | testing,*** while     | legislation should   |
|                       | enhancing             | be applied in a      |
|                       | competitiveness and   | non-discriminatory   |
|                       | innovation ***in      | manner whether       |
|                       | accordance with the   | substances are       |
|                       | duty of care, and     | traded on the        |
|                       | having due regard for | internal market or   |
|                       | the obligations       | internationally      |
|                       | entered into by the   | ***in accordance     |
|                       | EU and its Member     | with the             |
|                       | States in the         | Community\'s         |
|                       | framework of          | international        |
|                       | international trade   | commitments.***      |
|                       | agreements, in        |                      |
|                       | particular within the | Note: See Amendment  |
|                       | WTO***.               | 26 for animal        |
|                       |                       | welfare aspect under |
|                       |                       | heading \"Animal     |
|                       |                       | welfare\".           |
+-----------------------+-----------------------+----------------------+
| Article 1.3 a, b, and | Amendment 28          | A new recital        |
| c                     |                       | explaining that the  |
|                       | 3a. Any manufacturer, | duty of care is      |
| Do not exist.         | importer or           | effectively covered  |
|                       | downstream user       | by fulfilling the    |
|                       | performing or         | duties of this       |
|                       | intending to perform  | Regulation and other |
|                       | operations involving  | associated           |
|                       | a substance or        | legislation is       |
|                       | preparation, or an    | added.               |
|                       | article containing    |                      |
|                       | such a substance or   | ***Recital (new)***  |
|                       | preparation,          |                      |
|                       | including the         | ***This Regulation   |
|                       | manufacturing,        | lays down specific   |
|                       | importation and       | duties and           |
|                       | application thereof,  | obligations on       |
|                       | who knows or could    | manufacturers,       |
|                       | reasonably have       | importers and        |
|                       | foreseen that these   | downstream users of  |
|                       | operations could      | substances on their  |
|                       | adversely affect      | own, in preparations |
|                       | human health or the   | and in articles. The |
|                       | environment, shall    | Regulation is based  |
|                       | make every effort     | on the principle     |
|                       | that may reasonably   | that industry should |
|                       | be required of him to | manufacture, import  |
|                       | prevent, limit or     | or use substances or |
|                       | remedy such effects.  | place them on the    |
|                       |                       | market with such     |
|                       | 3b. Any manufacturer, | responsibility and   |
|                       | importer or           | care as may be       |
|                       | downstream user that  | required to ensure   |
|                       | supplies, in the      | that, under          |
|                       | pursuit of his        | reasonably           |
|                       | profession or         | foreseeable          |
|                       | business, a substance | conditions, human    |
|                       | or preparation, or an | health and the       |
|                       | article containing    | environment are not  |
|                       | such a substance or   | adversely            |
|                       | preparation, to a     | affected.***         |
|                       | manufacturer,         |                      |
|                       | importer or           | ***All available and |
|                       | downstream user       | relevant information |
|                       | shall, to the extent  | on substances on     |
|                       | this may reasonably   | their own, in        |
|                       | be required, ensure   | preparations and in  |
|                       | adequate              | articles should be   |
|                       | communication and     | collected to assist  |
|                       | information exchange, | in identifying       |
|                       | including where       | hazardous            |
|                       | appropriate technical | properties, and      |
|                       | assistance,           | recommendations      |
|                       | reasonably necessary  | about risk           |
|                       | to prevent, limit or  | management measures  |
|                       | remedy adverse        | should               |
|                       | effects on human      | systematically be    |
|                       | health or the         | conveyed through     |
|                       | environment.          | supply chains, as    |
|                       |                       | reasonably           |
|                       | 3c. This includes the | necessary, to        |
|                       | duty to describe,     | prevent adverse      |
|                       | document and notify   | effects on human     |
|                       | in an appropriate and | health and the       |
|                       | transparent fashion   | environment. In      |
|                       | the risks stemming    | addition,            |
|                       | from the production,  | communication of     |
|                       | use and disposal of   | technical advise to  |
|                       | each substance.       | support risk         |
|                       | Producers and         | management should be |
|                       | downstream users      | encouraged in the    |
|                       | shall select a        | supply chain, where  |
|                       | substance for         | appropriate**.*      |
|                       | production and use on |                      |
|                       | the basis of the      |                      |
|                       | safest substances     |                      |
|                       | available.            |                      |
+-----------------------+-----------------------+----------------------+

+-----------------------+-----------------------+----------------------+
| Article 14.7 a and b  | Amendment 48          | **It was agreed that |
|                       |                       | the elements of the  |
| Do not exist.         | ***7a. The            | EP amendment are     |
|                       | manufacturer or       | covered by Articles  |
|                       | importer of a         | 31, 32 and 36.**     |
|                       | substance or          |                      |
|                       | preparation who       |                      |
|                       | supplies such a       |                      |
|                       | substance or          |                      |
|                       | preparation to a      |                      |
|                       | downstream user       |                      |
|                       | shall, at the request |                      |
|                       | of the downstream     |                      |
|                       | user and in so far as |                      |
|                       | this can reasonably   |                      |
|                       | be requested, supply  |                      |
|                       | the information       |                      |
|                       | needed to assess the  |                      |
|                       | effects of the        |                      |
|                       | substance or          |                      |
|                       | preparation on human  |                      |
|                       | health or the         |                      |
|                       | environment in the    |                      |
|                       | context of the        |                      |
|                       | operations or use     |                      |
|                       | indicated by the      |                      |
|                       | downstream user in    |                      |
|                       | his request.***       |                      |
|                       |                       |                      |
|                       | ***7b. The downstream |                      |
|                       | user shall supply, at |                      |
|                       | the request of his    |                      |
|                       | supplier and in so    |                      |
|                       | far as this can       |                      |
|                       | reasonably be         |                      |
|                       | requested, the        |                      |
|                       | information needed by |                      |
|                       | the supplier to       |                      |
|                       | assess the effects of |                      |
|                       | the substance or      |                      |
|                       | preparation on human  |                      |
|                       | health or the         |                      |
|                       | environment in the    |                      |
|                       | context of the        |                      |
|                       | operations or use of  |                      |
|                       | the substance or      |                      |
|                       | preparation by the    |                      |
|                       | downstream user.***   |                      |
+-----------------------+-----------------------+----------------------+

**2. ANIMAL WELFARE**

+-----------------------+-----------------------+----------------------+
| **Council Common      | **EP amendment**      | **Result of the 6th  |
| Position**            |                       | trilogue**           |
+-----------------------+-----------------------+----------------------+
| Recital 58 a          | Amendment 17          | A new recital is     |
|                       |                       | added: (linked to    |
| Does not exist.       | ***(58a) In order to  | amendment 66):       |
|                       | prevent duplication   |                      |
|                       | of animal testing,    | ***(58a) In order to |
|                       | interested parties    | prevent unnecessary  |
|                       | should have a period  | animal testing,      |
|                       | of 90 days during     | interested parties   |
|                       | which they may        | should have a period |
|                       | comment on testing    | of 45 days during    |
|                       | proposals that        | which they may       |
|                       | include vertebrate    | provide              |
|                       | animal tests.         | scientifically valid |
|                       | Comments received     | information and      |
|                       | during this period    | studies that address |
|                       | should be taken into  | the relevant         |
|                       | account by the        | substance and hazard |
|                       | registrant or the     | end-point, which is  |
|                       | downstream user.***   | addressed by the     |
|                       |                       | testing proposal.    |
|                       |                       | The scientifically   |
|                       |                       | valid information    |
|                       |                       | and studies received |
|                       |                       | by the Agency shall  |
|                       |                       | be taken into        |
|                       |                       | account for          |
|                       |                       | decisions on testing |
|                       |                       | proposals.***        |
+-----------------------+-----------------------+----------------------+
| Article 1.1           | Amendment 26          | In order to address  |
|                       |                       | the animal welfare   |
| 1\. The purpose of    | 1\. The purpose of    | element of Amendment |
| this Regulation is to | this Regulation is to | 26 paragraph 1 is    |
| ensure a high level   | ensure a high level   | added as follows:    |
| of protection of      | of protection of      |                      |
| human health and the  | human health and the  | 1\. The purpose of   |
| environment ***as     | environment, the free | this Regulation is   |
| well as*** the free   | circulation of        | to ensure a high     |
| circulation of        | substances on the     | level of protection  |
| substances on the     | internal market***,   | of human health and  |
| internal market while | increased             | the environment,     |
| enhancing             | transparency and the  | ***including         |
| competitiveness and   | promotion of          | promotion of         |
| innovation.           | non-animal            | alternative methods  |
|                       | testing,*** while     | for assessment of    |
|                       | enhancing             | hazards of           |
|                       | competitiveness and   | substances,*** as    |
|                       | innovation ***in      | well as the free     |
|                       | accordance with the   | circulation of       |
|                       | duty of care, and     | substances on the    |
|                       | having due regard for | internal market      |
|                       | the obligations       | while enhancing      |
|                       | entered into by the   | competitiveness and  |
|                       | EU and its Member     | innovation.          |
|                       | States in the         |                      |
|                       | framework of          |                      |
|                       | international trade   |                      |
|                       | agreements, in        |                      |
|                       | particular within the |                      |
|                       | WTO***.               |                      |
+-----------------------+-----------------------+----------------------+
| Article 2.4 a         | Amendment 32          | New Recital and a    |
|                       |                       | new paragraph (b) in |
| Does not exist.       | ***4a. This           | Article 2.4 are      |
|                       | Regulation shall      | introduced in order  |
|                       | apply without         | to respond to the    |
|                       | prejudice to the      | concern regarding    |
|                       | prohibitions and      | testing of           |
|                       | restrictions laid     | substances in        |
|                       | down in Council       | cosmetic products on |
|                       | Directive 76/768/EEC  | animals.             |
|                       | of 27 July 1976 on    |                      |
|                       | the approximation of  | *Recital (New)*      |
|                       | the laws of the       |                      |
|                       | Member States         | ***(xx) This         |
|                       | relating to cosmetic  | Regulation should    |
|                       | products^(1)^,        | apply without        |
|                       | concerning:***        | prejudice to the     |
|                       |                       | prohibitions and     |
|                       | ***(i) the            | restrictions laid    |
|                       | prohibition of animal | down in Council      |
|                       | testing of finished   | Directive 76/768/EEC |
|                       | cosmetic products and | of 27 July 1976 on   |
|                       | the ingredients or    | the approximation of |
|                       | combinations of       | the laws of the      |
|                       | ingredients thereof;  | Member States        |
|                       | and***                | relating to cosmetic |
|                       |                       | products in that so  |
|                       | ***(ii) the marketing | far as substances    |
|                       | of cosmetic products  | are used and         |
|                       | of which some or all  | marketed as cosmetic |
|                       | of the ingredients,   | ingredients and are  |
|                       | or the final          | within the scope of  |
|                       | formulation, have     | this Regulation, a   |
|                       | been tested on        | phase-out of testing |
|                       | animals.***           | on vertebrate        |
|                       |                       | animals for the      |
|                       | ***To the extent that | purpose of           |
|                       | substances used only  | protecting human     |
|                       | as cosmetic           | health as specified  |
|                       | ingredients are       | in Directive         |
|                       | covered by this       | 76/768/EEC should    |
|                       | Regulation, no animal | take place with      |
|                       | testing that is       | regard to the uses   |
|                       | prohibited pursuant   | of those substances  |
|                       | to Directive          | in cosmetics.***     |
|                       | 76/768/EEC as amended |                      |
|                       | shall be permitted    | *Article 2.4*        |
|                       | for the purposes of   |                      |
|                       | the same assessment   | This Regulation      |
|                       | required by this      | shall apply without  |
|                       | Regulation with       | prejudice to:        |
|                       | regard to such        |                      |
|                       | substances.***        | **(a)** Community    |
|                       |                       | workplace and        |
|                       | ***\_\_               | environmental        |
|                       | \_\_\_\_\_\_\_\_\_*** | legislation,         |
|                       |                       | including Council    |
|                       | ***^(1)^ OJ L 262,    | Directive            |
|                       | 27.7.1976, p. 169.    | 89/391/EEC^(2)^ of   |
|                       | Directive as amended  | 12 June 1989 on the  |
|                       | by Directive          | introduction of      |
|                       | 2003/15/EC (OJ L 66,  | measures to          |
|                       | 11.3.2003, p. 26) and | encourage            |
|                       | as last amended by    | improvements in the  |
|                       | Commission Directive  | safety and health of |
|                       | 2006/65/EC (OJ L 198, | workers at work,     |
|                       | 20.7.2006)***         | Council Directive    |
|                       |                       | 96/61/EC^(3)^ of 24  |
|                       |                       | September 1996       |
|                       |                       | concerning           |
|                       |                       | integrated pollution |
|                       |                       | prevention and       |
|                       |                       | control; Directive   |
|                       |                       | 98/24/EC^(4)^,       |
|                       |                       | Directive            |
|                       |                       | 2000/60/EC^(5)^ of   |
|                       |                       | the European         |
|                       |                       | Parliament and of    |
|                       |                       | the Council of 23    |
|                       |                       | October 2000         |
|                       |                       | establishing a       |
|                       |                       | framework for        |
|                       |                       | Community action in  |
|                       |                       | the field of water   |
|                       |                       | policy and Directive |
|                       |                       | 2004/37/EC^(6)^.     |
|                       |                       |                      |
|                       |                       | > **(*b) Council     |
|                       |                       | > Directive          |
|                       |                       | >                    |
|                       |                       |  76/768/EEC****^(7)^ |
|                       |                       | > **of 27 July 1976  |
|                       |                       | > on the             |
|                       |                       | > approximation of   |
|                       |                       | > the laws of the    |
|                       |                       | > Member States      |
|                       |                       | > relating to        |
|                       |                       | > cosmetic products  |
|                       |                       | > as regard to       |
|                       |                       | > testing involving  |
|                       |                       | > vertebrate animals |
|                       |                       | > within the scope   |
|                       |                       | > of that Directive. |
|                       |                       | > ***                |
|                       |                       |                      |
|                       |                       | ***\_\_\_\_\_\       |
|                       |                       | _\_\_\_\_\_\_\_\_*** |
|                       |                       |                      |
|                       |                       | ^(1)-(7)^ references |
|                       |                       | to the relevant OJ   |
|                       |                       | issues               |
+-----------------------+-----------------------+----------------------+

+-----------------------+-----------------------+----------------------+
| Article 12.2 a        | Amendment 42          | This issue is        |
|                       |                       | addressed in the     |
| Does not exist.       | ***2a. Priority shall | context of Amendment |
|                       | be given to in vitro  | 45 (Article          |
|                       | methods and the use   | 13.2.1.a).           |
|                       | of (quantitative)     |                      |
|                       | structure activity    |                      |
|                       | relationships         |                      |
|                       | ((Q)SARs). To this    |                      |
|                       | end, the Agency shall |                      |
|                       | make available to     |                      |
|                       | companies a list of   |                      |
|                       | tests, databases and  |                      |
|                       | approved models.***   |                      |
+-----------------------+-----------------------+----------------------+
| Article 13.1          | Amendment 43          | This issue is        |
|                       |                       | addressed in the     |
| 1\. Information on    | 1\. Information on    | context of Amendment |
| intrinsic properties  | intrinsic properties  | 45 (Article          |
| of substances         | of substances***, in  | 13.2.1.a) and by the |
| ***may*** be          | particular for human  | following text:      |
| generated by means    | toxicity, shall*** be |                      |
| other than tests, in  | generated ***whenever | *Article 13*         |
| particular through    | possible*** by means  |                      |
| the use of            | other than            | 1\. Information on   |
| qualitative or        | ***vertebrate         | intrinsic properties |
| quantitative          | animal*** tests, in   | of substances        |
| structure-activity    | particular through    | ***may*** be         |
| relationship models   | the use of            | generated by means   |
| or from information   | qualitative or        | other than tests,    |
| from structurally     | quantitative          | ***provided that the |
| related substances    | structure-activity    | conditions set out   |
| (grouping or          | relationship models   | in Annex XI are      |
| read-across),         | or from information   | met***. ***In        |
| provided that the     | from structurally     | particular for human |
| conditions set out in | related substances    | toxicity,            |
| Annex XI are met.     | (grouping or          | information shall be |
| Testing in accordance | read-across),         | generated whenever   |
| with Annex VIII,      | provided that the     | possible by means    |
| section 8.6 and 8.7,  | conditions set out in | other than           |
| Annex IX and Annex X  | Annex XI are met***,  | vertebrate animal    |
| may be omitted where  | or toxicogenomics***. | tests, through the   |
| justified by          | Testing in accordance | use of alternative   |
| information on        | with Annex VIII,      | methods, for         |
| exposure and          | section 8.6 and 8.7,  | example, in vitro    |
| implemented risk      | Annex IX and Annex X  | methods or***        |
| management measures   | may be omitted where  | qualitative or       |
| as specified in       | justified by          | quantitative         |
| Annex XI, section 3.  | information on        | structure-activity   |
|                       | exposure and          | relationship models  |
|                       | implemented risk      | or from information  |
|                       | management measures   | from structurally    |
|                       | as specified in       | related substances   |
|                       | Annex XI, section 3.  | (grouping or         |
|                       |                       | read-across)         |
|                       |                       | ~~provided that the  |
|                       |                       | conditions set out   |
|                       |                       | in Annex XI are      |
|                       |                       | met.~~ Testing in    |
|                       |                       | accordance with      |
|                       |                       | Annex VIII, section  |
|                       |                       | 8.6 and 8.7, Annex   |
|                       |                       | IX and Annex X may   |
|                       |                       | be omitted where     |
|                       |                       | justified by         |
|                       |                       | information on       |
|                       |                       | exposure and         |
|                       |                       | implemented risk     |
|                       |                       | management measures  |
|                       |                       | as specified in      |
|                       |                       | Annex XI, section 3. |
+-----------------------+-----------------------+----------------------+
| Article 13.2.1 a      | Amendment 45          | Recitals (36) and    |
|                       |                       | (43) are amended to  |
| Does not exist.       | ***These methods      | read as below and    |
|                       | shall be regularly    | the Commission will  |
| ***\_\_\_\_\_\_       | reviewed and improved | make the statement   |
| \_\_\_\_\_\_\_\_\_*** | with a view to        | set out in Annex B   |
|                       | reducing              | to this Note. In     |
| Recitals              | experimentation on    | Article 13 a new     |
|                       | vertebrate animals    | paragraph 1a is      |
| ***(36)               | and the number of     | inserted and         |
| Internationally       | animals involved. In  | paragraph 2 is       |
| accepted test methods | particular, if the    | amended.             |
| should be recognised  | European Centre for   |                      |
| and other test        | the Validation of     | *Article 13*         |
| methods should be     | Alternative Methods   |                      |
| adopted by the        | (ECVAM) declares an   | ***1a. These methods |
| Commission and        | alternative test      | shall be regularly   |
| revised as            | method valid and      | reviewed and         |
| appropriate, in       | ready for regulatory  | improved with a view |
| particular to refine, | acceptance, the       | to reducing          |
| reduce or replace     | Agency shall submit   | experimentation on   |
| animal testing***.    | within 14 days a      | vertebrate animals   |
|                       | draft decision        | and the number of    |
| ***(43) It is         | amending the relevant | animals involved.    |
| necessary to reduce   | Annex(es) to this     | The Commission,      |
| to a minimum the      | Regulation, in        | following            |
| number of vertebrate  | accordance with the   | consultation with    |
| animals used for      | procedure provided    | relevant             |
| experimental purposes | for in Article 130,   | stakeholders, shall, |
| in accordance with    | with a view to        | as soon as possible, |
| the provisions of     | replacing the animal  | make a proposal, if  |
| Directive 86/609/EEC. | test method with the  | appropriate, to      |
| Wherever possible the | alternative one.***   | amend the test       |
| use of animals should |                       | methods Regulation,  |
| be avoided by         | ***\_\_\_\_\_\_       | and Annexes of this  |
| recourse to           | \_\_\_\_\_\_\_\_\_*** | Regulation, if       |
| alternative methods   |                       | relevant, so as to   |
| validated by the      |                       | replace, reduce or   |
| European Centre for   |                       | refine animal        |
| the Validation of     |                       | testing.             |
| Alternative Methods   |                       | Modifications of the |
| or other              |                       | test methods         |
| international bodies  |                       | Regulation shall be  |
| and recognised by the |                       | adopted in           |
| Commission or the     |                       | accordance with the  |
| Agency as             |                       | procedure specified  |
| appropriate.***       |                       | in paragraph 2 and   |
|                       |                       | of Annexes of this   |
|                       |                       | Regulation in        |
|                       |                       | accordance with      |
|                       |                       | Article 130.***      |
|                       |                       |                      |
|                       |                       | 2\. Where tests on   |
|                       |                       | substances are       |
|                       |                       | required to generate |
|                       |                       | information on       |
|                       |                       | intrinsic properties |
|                       |                       | of substances, they  |
|                       |                       | shall be conducted   |
|                       |                       | in accordance with   |
|                       |                       | the test methods     |
|                       |                       | laid down in a       |
|                       |                       | Commission           |
|                       |                       | Regulation adopted   |
|                       |                       | in accordance with   |
|                       |                       | the procedure        |
|                       |                       | referred to in       |
|                       |                       | Article 132(3),      |
|                       |                       | ~~which shall be     |
|                       |                       | revised as           |
|                       |                       | appropriate in       |
|                       |                       | particular to        |
|                       |                       | refine, reduce or    |
|                       |                       | replace animal       |
|                       |                       | testing~~ or in      |
|                       |                       | accordance with      |
|                       |                       | other international  |
|                       |                       | test methods         |
|                       |                       | recognised by the    |
|                       |                       | Commission or the    |
|                       |                       | Agency as being      |
|                       |                       | appropriate.         |
|                       |                       |                      |
|                       |                       | Information on       |
|                       |                       | intrinsic properties |
|                       |                       | of substances may be |
|                       |                       | generated in         |
|                       |                       | accordance with      |
|                       |                       | other test methods   |
|                       |                       | provided that the    |
|                       |                       | conditions set out   |
|                       |                       | in Annex XI are met. |
|                       |                       |                      |
|                       |                       | ***\_\_\_\_\         |
|                       |                       | _\_\_\_\_\_\_\_\_*** |
|                       |                       |                      |
|                       |                       | Recitals             |
|                       |                       |                      |
|                       |                       | ***(36) The          |
|                       |                       | Commission, Member   |
|                       |                       | States, industry and |
|                       |                       | other stakeholders   |
|                       |                       | should continue to   |
|                       |                       | contribute to the    |
|                       |                       | promotion of         |
|                       |                       | alternative test     |
|                       |                       | methods on an        |
|                       |                       | international and    |
|                       |                       | national level       |
|                       |                       | including computer   |
|                       |                       | supported            |
|                       |                       | methodologies, in    |
|                       |                       | vitro methodologies, |
|                       |                       | such as appropriate, |
|                       |                       | those based on       |
|                       |                       | toxicogenomics, and  |
|                       |                       | other relevant       |
|                       |                       | methodologies. The   |
|                       |                       | Community's strategy |
|                       |                       | to promote           |
|                       |                       | alternative test     |
|                       |                       | methods is a         |
|                       |                       | priority and the     |
|                       |                       | Commission should    |
|                       |                       | ensure that within   |
|                       |                       | its future Research  |
|                       |                       | Framework Programmes |
|                       |                       | and initiatives such |
|                       |                       | as the Community     |
|                       |                       | Action Plan on the   |
|                       |                       | Protection and       |
|                       |                       | Welfare of Animals   |
|                       |                       | 2006-2010 this       |
|                       |                       | remains a priority   |
|                       |                       | topic. Participation |
|                       |                       | of stakeholders and  |
|                       |                       | initiatives          |
|                       |                       | involving all        |
|                       |                       | interested parties   |
|                       |                       | should be sought.*** |
|                       |                       |                      |
|                       |                       | ***(43) In           |
|                       |                       | accordance with the  |
|                       |                       | provisions of        |
|                       |                       | Directive            |
|                       |                       | 86/609/EEC, it is    |
|                       |                       | necessary to         |
|                       |                       | replace, reduce or   |
|                       |                       | refine experiments   |
|                       |                       | on vertebrate        |
|                       |                       | an                   |
|                       |                       | imals[.]{.underline} |
|                       |                       | Implementation of    |
|                       |                       | this Regulation      |
|                       |                       | should be based on   |
|                       |                       | the use of           |
|                       |                       | alternative test     |
|                       |                       | methods, suitable    |
|                       |                       | for the assessment   |
|                       |                       | of health and        |
|                       |                       | environmental        |
|                       |                       | hazards of           |
|                       |                       | chemicals, wherever  |
|                       |                       | possible. The use of |
|                       |                       | animals should be    |
|                       |                       | avoided by recourse  |
|                       |                       | to alternative       |
|                       |                       | methods validated by |
|                       |                       | the Commission or    |
|                       |                       | international        |
|                       |                       | bodies, or           |
|                       |                       | recognised by the    |
|                       |                       | Commission or the    |
|                       |                       | Agency as            |
|                       |                       | appropriate to meet  |
|                       |                       | the information      |
|                       |                       | requirements under   |
|                       |                       | this Regulation. To  |
|                       |                       | this end, the        |
|                       |                       | Commission,          |
|                       |                       | following            |
|                       |                       | consultation with    |
|                       |                       | relevant             |
|                       |                       | stakeholders, should |
|                       |                       | propose to amend the |
|                       |                       | test methods         |
|                       |                       | Regulation or this   |
|                       |                       | Regulation, where    |
|                       |                       | appropriate, to      |
|                       |                       | replace, reduce or   |
|                       |                       | refine animal        |
|                       |                       | testing. The         |
|                       |                       | Commission and the   |
|                       |                       | Agency should ensure |
|                       |                       | that reduction of    |
|                       |                       | animal testing is a  |
|                       |                       | key consideration in |
|                       |                       | the development and  |
|                       |                       | maintenance of       |
|                       |                       | guidance for         |
|                       |                       | stakeholders and in  |
|                       |                       | the Agency's own     |
|                       |                       | procedures.***       |
+-----------------------+-----------------------+----------------------+

+-----------------------+-----------------------+----------------------+
| Article 39.1 a        | Amendment 66          | The following new    |
|                       |                       | paragraph is         |
| Does not exist.       | ***1a. In order to    | inserted (linked to  |
|                       | prevent duplication   | amendment 12)        |
|                       | of animal testing,    |                      |
|                       | any testing proposal  | Article 39           |
|                       | involving tests on    |                      |
|                       | vertebrate animals    | *Examination of      |
|                       | shall be open for     | testing proposals*   |
|                       | comment by interested |                      |
|                       | parties for a period  | 1\. The Agency shall |
|                       | of 90 days. All       | examine any testing  |
|                       | comments received     | proposal set out in  |
|                       | shall be taken into   | a registration or    |
|                       | account by the        | downstream user      |
|                       | registrant or the     | report for provision |
|                       | downstream user, who  | of the information   |
|                       | shall notify the      | specified in Annexes |
|                       | Agency whether, in    | IX and X for a       |
|                       | the light of the      | substance. ....      |
|                       | comments received, he |                      |
|                       | nonetheless believes  | ***1a. Information   |
|                       | that it is necessary  | relating to testing  |
|                       | to carry out the      | proposals involving  |
|                       | proposed test and of  | tests on vertebrate  |
|                       | his reasons           | animals shall be     |
|                       | therefor.***          | published on the     |
|                       |                       | Agency website. The  |
|                       |                       | Agency shall publish |
|                       |                       | on its website the   |
|                       |                       | name of the          |
|                       |                       | substance, the       |
|                       |                       | hazard end-point for |
|                       |                       | which vertebrate     |
|                       |                       | testing is proposed, |
|                       |                       | and the date by      |
|                       |                       | which any third      |
|                       |                       | party information is |
|                       |                       | required. It shall   |
|                       |                       | invite third parties |
|                       |                       | to submit, using the |
|                       |                       | format provided by   |
|                       |                       | the                  |
|                       |                       | Ag                   |
|                       |                       | ency, scientifically |
|                       |                       | valid information    |
|                       |                       | and studies that     |
|                       |                       | address the relevant |
|                       |                       | substance and hazard |
|                       |                       | end-point, and       |
|                       |                       | addressed by the     |
|                       |                       | testing proposal,    |
|                       |                       | within 45 days of    |
|                       |                       | the date of          |
|                       |                       | publication. All     |
|                       |                       | such scientifically  |
|                       |                       | valid information    |
|                       |                       | and studies received |
|                       |                       | shall be taken into  |
|                       |                       | account by the       |
|                       |                       | Agency in preparing  |
|                       |                       | its decision in      |
|                       |                       | accordance with      |
|                       |                       | Article 39.(2).***   |
+-----------------------+-----------------------+----------------------+
| Article 39.1 b        | Amendment 67          | This issue is        |
|                       |                       | addressed in the     |
| Does not exist.       | ***1b. The European   | context of Amendment |
|                       | Centre for the        | 45 (Article          |
|                       | Validation of         | 13.2.1.a) and by the |
|                       | Alternative Methods   | Commission Statement |
|                       | (ECVAM) shall be      | in Annex B.          |
|                       | consulted before a    |                      |
|                       | decision as referred  |                      |
|                       | to in paragraph 2 on  |                      |
|                       | a testing proposal    |                      |
|                       | that includes         |                      |
|                       | vertebrate animal     |                      |
|                       | tests is drafted.***  |                      |
+-----------------------+-----------------------+----------------------+

+-----------------------+-----------------------+----------------------+
| Article 49.1          | Amendment 72          | This issue is        |
|                       |                       | addressed in the     |
| 1\. The Agency shall  | 1\. The Agency shall  | context of Amendment |
| notify any draft      | notify any draft      | 66 (Article 39.1.a)  |
| decision under        | decision under        | and by the           |
| Articles 39, 40 or 45 | Articles 39, 40 or    | Commission Statement |
| to the registrant(s)  | 45, ***together with  | in Annex B.          |
| or downstream user(s) | any comments by       |                      |
| concerned, informing  | stakeholders and the  |                      |
| them of their right   | European Centre for   |                      |
| to comment within 30  | the Validation of     |                      |
| days of receipt. If   | Alternative Methods   |                      |
| the concerned         | (ECVAM),*** to the    |                      |
| registrant(s) or      | registrant(s) or      |                      |
| downstream user(s)    | downstream user(s)    |                      |
| wish to comment, they | concerned***,***      |                      |
| shall provide their   | informing them of     |                      |
| comments to the       | their right to        |                      |
| Agency. The Agency in | comment within 30     |                      |
| turn shall inform the | days of receipt. If   |                      |
| competent authority   | the concerned         |                      |
| of the submission of  | registrant(s) or      |                      |
| the comments without  | downstream user(s)    |                      |
| delay. The competent  | wish to comment, they |                      |
| authority (for        | shall provide their   |                      |
| decisions taken under | comments to the       |                      |
| Article 45) and the   | Agency. The Agency in |                      |
| Agency (for decisions | turn shall inform the |                      |
| taken under Articles  | competent authority   |                      |
| 39 and 40) shall take | of the submission of  |                      |
| any comments received | the comments without  |                      |
| into account and may  | delay. The competent  |                      |
| amend the draft       | authority (for        |                      |
| decision accordingly. | decisions taken under |                      |
|                       | Article 45) and the   |                      |
|                       | Agency (for decisions |                      |
|                       | taken under Articles  |                      |
|                       | 39 and 40) shall take |                      |
|                       | any comments received |                      |
|                       | into account and may  |                      |
|                       | amend the draft       |                      |
|                       | decision accordingly. |                      |
+-----------------------+-----------------------+----------------------+
| Article 75.1 da       | Amendment 122         | The concern is       |
|                       |                       | addressed in the     |
| Does not exist.       | ***(da) a Committee   | context of amendment |
|                       | for Alternative Test  | 45 (Article          |
|                       | Methods, which shall  | 13.2.1.a) and in the |
|                       | be responsible for    | following text:      |
|                       | developing and        |                      |
|                       | implementing an       | ***[Article          |
|                       | integrated strategy   | 116]{.underline}***  |
|                       | to speed up the       |                      |
|                       | development,          | ***2.(a )(new)       |
|                       | validation and legal  | Every three years    |
|                       | acceptance of         | the Agency, in       |
|                       | non-animal test       | accordance with the  |
|                       | methods, and to       | objective of         |
|                       | ensure their use in   | promoting non-animal |
|                       | intelligent stepwise  | testing              |
|                       | risk assessment to    | me                   |
|                       | meet the requirements | thods[,]{.underline} |
|                       | of this Regulation.   | shall submit to the  |
|                       | The Committee shall   | Commission a report  |
|                       | be responsible for    | on the status of     |
|                       | allocating funding    | implementation and   |
|                       | for alternative test  | use of non-animal    |
|                       | methods provided      | test methods and     |
|                       | through the           | testing strategies   |
|                       | registration fee. The | used to generate     |
|                       | Committee shall       | information on       |
|                       | consist of experts    | intrinsic properties |
|                       | from the European     | and for risk         |
|                       | Centre for the        | assessment to meet   |
|                       | Validation of         | the requirements of  |
|                       | Alternative Methods,  | this Regulation.***  |
|                       | animal welfare        |                      |
|                       | organisations and     | ***The first report  |
|                       | other relevant        | shall be submitted   |
|                       | stakeholders.***      | by...\*\****         |
|                       |                       |                      |
|                       | ***Every year the     | 3\. Every five years |
|                       | Committee shall       | the Commission shall |
|                       | produce a report to   | publish a general    |
|                       | be presented by the   | report on            |
|                       | Agency to the         |                      |
|                       | European Parliament   | 1\) the experience   |
|                       | and the Council on    | acquired with the    |
|                       | the progress made on  | operation of this    |
|                       | the development,      | Regulation,          |
|                       | validation and legal  | including the        |
|                       | acceptance of         | information referred |
|                       | non-animal test       | to in paragraphs 1,  |
|                       | methods, the use of   | 2 ***and 2(a) and*** |
|                       | such methods in       |                      |
|                       | intelligent stepwise  | ***2) the amount and |
|                       | risk assessment to    | distribution of      |
|                       | meet the requirements | funding made         |
|                       | of this Regulation,   | available by the     |
|                       | and the amount and    | European Commission  |
|                       | distribution of       | for the development  |
|                       | funding for           | and evaluation of    |
|                       | alternative test      | alternative test     |
|                       | methods.***           | methods***.          |
|                       |                       |                      |
|                       |                       | *\*\* 4 years*       |
+-----------------------+-----------------------+----------------------+

**3. COMMUNICATION OF INFORMATION**

+-----------------------+-----------------------+----------------------+
| **Council Common      | **EP amendment**      | **Result of the 6th  |
| Position**            |                       | trilogue**           |
+-----------------------+-----------------------+----------------------+
| Recital 85            | Amendment 21          | A new recital is     |
|                       |                       | introduced to take   |
| \(85\) The structure  | \(85\) The structure  | account of concerns  |
| of the Agency should  | of the Agency should  | behind Amendment     |
| be suitable for the   | be suitable for the   | 125:                 |
| tasks that it should  | tasks that it should  |                      |
| fulfil. Experience    | fulfil. Experience    | ***Recital***        |
| with similar          | with similar          |                      |
| Community agencies    | Community agencies    | ***(85(bis)) The     |
| provides some         | provides some         | effective            |
| guidance in this      | guidance in this      | communication of     |
| respect but the       | respect but the       | information on       |
| structure should be   | structure should be   | chemical risks and   |
| adapted to meet the   | adapted to meet the   | how they can be      |
| specific needs of     | specific needs of     | managed is an        |
| this Regulation.      | this Regulation.      | essential part of    |
|                       | ***In this respect, a | the REACH system.    |
|                       | centre of excellence  | Best practice from   |
|                       | specialised in        | the chemicals and    |
|                       | communication of the  | other sectors should |
|                       | risks and dangers     | be considered in the |
|                       | associated with       | preparation of       |
|                       | certain substances    | guidance by the      |
|                       | and preparations      | Agency to all        |
|                       | should be created     | stakeholders.***     |
|                       | within the Agency.*** |                      |
+-----------------------+-----------------------+----------------------+
| Article 3.25          | Amendment 34          | It was agreed not    |
|                       |                       | the amend Article    |
| 25\) Identified use:  | 25\) Identified use:  | 3.25.                |
| means a use of a      | means a use of a      |                      |
| substance on its own  | substance on its own  | 25\) Identified use: |
| or in a preparation,  | or in a preparation,  | means a use of a     |
| or a use of a         | or a use of a         | substance on its own |
| preparation, that is  | preparation, that is  | or in a preparation, |
| intended by an actor  | intended by an actor  | or a use of a        |
| in the supply chain,  | in the supply chain,  | preparation, that is |
| including his own     | including his own     | intended by an actor |
| use, or that is made  | use, or that is made  | in the supply chain, |
| known to him in       | known to him in       | including his own    |
| writing by an         | writing by an         | use, or that is made |
| immediate downstream  | immediate downstream  | known to him in      |
| user;                 | user***, and that is  | writing by an        |
|                       | communicated to the   | immediate downstream |
|                       | downstream user       | user;                |
|                       | concerned***;         |                      |
+-----------------------+-----------------------+----------------------+
| Article 8 a           | Amendment 40          | A new recital is     |
|                       |                       | introduced to        |
| Does not exist.       | ***Article 8a***      | respond to the       |
|                       |                       | issues raised on     |
|                       | ***European quality   | this amendment.      |
|                       | mark***               |                      |
|                       |                       | ***(xy) REACH will   |
|                       | ***By .... \* the     | generate information |
|                       | Commission shall      | on substances and    |
|                       | present to the        | their uses.          |
|                       | European Parliament   | Available            |
|                       | and the Council a     | information,         |
|                       | report and, if        | including that       |
|                       | appropriate, a        | generated by REACH,  |
|                       | legislative proposal  | should be used by    |
|                       | on the creation of a  | the relevant actor   |
|                       | European quality mark | in the application   |
|                       | designed to identify  | and implementation   |
|                       | and promote articles  | of appropriate       |
|                       | which, at each stage  | Community            |
|                       | of the production     | legislation, for     |
|                       | process, have been    | example those        |
|                       | produced in           | covering products,   |
|                       | compliance with the   | and Community        |
|                       | requirements stemming | voluntary            |
|                       | from this             | instruments, such as |
|                       | Regulation.***        | the eco-labelling    |
|                       |                       | scheme. The          |
|                       | ***\_\_\_\_\_***      | Commission should    |
|                       |                       | consider in the      |
|                       | ***\* Two years after | review and           |
|                       | the entry into force  | development of       |
|                       | of this               | relevant EU          |
|                       | Regulation.***        | legislation and      |
|                       |                       | voluntary            |
|                       |                       | instruments how      |
|                       |                       | REACH generated      |
|                       |                       | information should   |
|                       |                       | be used, and examine |
|                       |                       | possibilities for    |
|                       |                       | establishing a       |
|                       |                       | European quality     |
|                       |                       | mark.***             |
+-----------------------+-----------------------+----------------------+
| Article 31.1          | Amendment 61          | Article 31 is        |
|                       |                       | modified as follows: |
| 1\. The supplier of a | 1\. The supplier of a |                      |
| substance or          | substance or a        | *Article 31*         |
| preparation shall     | preparation shall     |                      |
| provide the recipient | provide the recipient | *Requirements for    |
| of the substance or   | of the substance or   | Safety Data Sheets*  |
| preparation with a    | preparation with a    |                      |
| safety data sheet     | safety data sheet     | 1\. The supplier of  |
| compiled in           | compiled in           | a substance or a     |
| accordance with Annex | accordance with Annex | preparation shall    |
| II:                   | II:                   | provide the          |
|                       |                       | recipient of the     |
| \(a\) where a         | \(a\) where a         | substance or         |
| substance or          | substance or          | preparation with a   |
| preparation meets the | preparation meets the | safety data sheet    |
| criteria for          | criteria for          | compiled in          |
| classification as     | classification as     | accordance with      |
| dangerous in          | dangerous in          | Annex II:            |
| accordance with       | accordance with       |                      |
| Directives 67/548/EEC | Directives 67/548/EEC | \(a\) where a        |
| or 1999/45/EC, or     | or 1999/45/EC; or     | substance or         |
|                       |                       | preparation meets    |
| \(b\) where a         | \(b\) where a         | the criteria for     |
| substance is          | substance is          | classification as    |
| persistent,           | persistent,           | dangerous in         |
| bioaccumulative and   | bioaccumulative and   | accordance with      |
| toxic or very         | toxic or very         | D                    |
| persistent and very   | persistent and very   | irectives 67/548/EEC |
| bioaccumulative in    | bioaccumulative in    | or 1999/45/EC, or    |
| accordance with the   | accordance with the   |                      |
| criteria set out in   | criteria set out in   | \(b\) where a        |
| Annex XIII.           | Annex XIII***; or***  | substance is         |
|                       |                       | persistent,          |
|                       | ***(ba) where a       | bioaccumulative and  |
|                       | substance has been    | toxic or very        |
|                       | identified in         | persistent and very  |
|                       | accordance with       | bioaccumulative in   |
|                       | Article 56 (f)***.    | accordance with the  |
|                       |                       | criteria set out in  |
|                       |                       | Annex XIII, or       |
|                       |                       |                      |
|                       |                       | ***(c) where a       |
|                       |                       | substance is         |
|                       |                       | included for other   |
|                       |                       | reasons than         |
|                       |                       | contained in         |
|                       |                       | paragraphs (a) and   |
|                       |                       | (b) in the list      |
|                       |                       | established in       |
|                       |                       | accordance with      |
|                       |                       | Article 58(1).***    |
|                       |                       |                      |
|                       |                       | \[2.                 |
|                       |                       | uncha                |
|                       |                       | nged[\]]{.underline} |
|                       |                       |                      |
|                       |                       | 3\. The supplier     |
|                       |                       | shall provide the    |
|                       |                       | recipient at his     |
|                       |                       | request with a       |
|                       |                       | safety data sheet    |
|                       |                       | compiled in          |
|                       |                       | accordance with      |
|                       |                       | Annex II, where a    |
|                       |                       | preparation does not |
|                       |                       | meet the criteria    |
|                       |                       | for classification   |
|                       |                       | as dangerous in      |
|                       |                       | accordance with      |
|                       |                       | Articles 5, 6 and 7  |
|                       |                       | of                   |
|                       |                       | D                    |
|                       |                       | irective 1999/45/EC, |
|                       |                       | but contains:        |
|                       |                       |                      |
|                       |                       | \(a\) (a) in an      |
|                       |                       | individual           |
|                       |                       | concentration of     |
|                       |                       | ≥ 1% by weight for   |
|                       |                       | non-gaseous          |
|                       |                       | preparations and     |
|                       |                       | ≥ 0,2% by volume for |
|                       |                       | gaseous preparations |
|                       |                       | at least one         |
|                       |                       | substance posing     |
|                       |                       | human health or      |
|                       |                       | environmental        |
|                       |                       | hazards, or          |
|                       |                       |                      |
|                       |                       | \(b\) in an          |
|                       |                       | individual           |
|                       |                       | concentration of ≥   |
|                       |                       | 0,1% by weight for   |
|                       |                       | non-gaseous          |
|                       |                       | preparations at      |
|                       |                       | least one substance  |
|                       |                       | that is persistent,  |
|                       |                       | bioaccumulative and  |
|                       |                       | toxic or very        |
|                       |                       | persistent and very  |
|                       |                       | bioaccumulative in   |
|                       |                       | accordance with the  |
|                       |                       | criteria set out in  |
|                       |                       | Annex ***XIII or has |
|                       |                       | been included in the |
|                       |                       | list established in  |
|                       |                       | accordance with      |
|                       |                       | Article 58(1),*** or |
|                       |                       |                      |
|                       |                       | \(c\) a substance    |
|                       |                       | for which there are  |
|                       |                       | Community workplace  |
|                       |                       | exposure limits.     |
|                       |                       |                      |
|                       |                       | \[4.                 |
|                       |                       | uncha                |
|                       |                       | nged[\]]{.underline} |
+-----------------------+-----------------------+----------------------+
| Article 32.4          | Amendment 63          | It was agreed to     |
|                       |                       | move the provisions  |
| ***4. Any producer or | ***deleted***         | of 32.(4) to a       |
| importer of an        |                       | specific Article on  |
| article containing a  |                       | \"Communication of   |
| substance meeting the |                       | information on       |
| criteria in           |                       | substances in        |
| Article 56 and        |                       | articles\".          |
| identified according  |                       |                      |
| to Article 58(1) in a |                       | See Amendment 64.    |
| concentration above   |                       |                      |
| 0.1 %  weight by      |                       |                      |
| weight (w/w), shall   |                       |                      |
| provide the recipient |                       |                      |
| of the article with   |                       |                      |
| sufficient            |                       |                      |
| information to allow  |                       |                      |
| safe use of the       |                       |                      |
| article including, as |                       |                      |
| a minimum, the name   |                       |                      |
| of the substance.     |                       |                      |
| This obligation shall |                       |                      |
| extend to all         |                       |                      |
| recipients of         |                       |                      |
| articles in the       |                       |                      |
| supply chain.***      |                       |                      |
+-----------------------+-----------------------+----------------------+
| Article 33 a          | Amendment 64          | The following new    |
|                       |                       | Article 32a is       |
| Does not exist.       | ***Article 33a***     | introduced, Article  |
|                       |                       | 3 is modified (see   |
|                       | ***Duty to            | 3.31a and 3.33       |
|                       | communicate           | below), and a new    |
|                       | information on        | paragraph 1a is      |
|                       | substances contained  | introduced in        |
|                       | in articles***        | Article 137.         |
|                       |                       |                      |
|                       | ***1. Any             | ***Article 32a       |
|                       | manufacturer or       | (new)***             |
|                       | importer of a         |                      |
|                       | substance listed in   | ***Duty to           |
|                       | Annex XIV, or a       | Communicate          |
|                       | preparation or        | information on       |
|                       | article containing    | Substances in        |
|                       | such a substance,     | Articles***          |
|                       | shall at the request  |                      |
|                       | of the downstream     | ***1 Any supplier of |
|                       | user, in so far as    | an article           |
|                       | this may reasonably   | containing a         |
|                       | be required, furnish  | substance meeting    |
|                       | the information       | the criteria in      |
|                       | necessary to assess   | Article 56 and       |
|                       | the effects of the    | identified according |
|                       | substance on human    | to Article 58(1) in  |
|                       | health or the         | a concentration      |
|                       | environment with      | above 0,1 % weight   |
|                       | respect to the        | by weight (w/w)      |
|                       | operations and uses   | shall provide the    |
|                       | indicated in that     | recipient of the     |
|                       | request.***           | article with         |
|                       |                       | sufficient           |
|                       | ***2. The information | information,         |
|                       | requirements          | available to the     |
|                       | specified in          | supplier, to allow   |
|                       | paragraph 1 shall     | safe use of the      |
|                       | apply mutatis         | article including,   |
|                       | mutandis up the       | as a minimum, the    |
|                       | supply chain.***      | name of that         |
|                       |                       | substance.***        |
|                       | ***3. Downstream      |                      |
|                       | users who incorporate | ***2. On request by  |
|                       | into an article a     | a consumer any       |
|                       | substance or          | supplier of an       |
|                       | preparation for which | article containing a |
|                       | a safety data sheet   | substance meeting    |
|                       | was established, and  | the criteria in      |
|                       | those who             | Article 56 and       |
|                       | subsequently handle   | identified according |
|                       | or further process    | to Article 58(1) in  |
|                       | that article, shall   | a concentration      |
|                       | pass on the safety    | above 0,1 % weight   |
|                       | data sheet to any     | by weight (w/w)      |
|                       | recipient of the      | shall provide the    |
|                       | article or its        | consumer with        |
|                       | derivative.           | sufficient           |
|                       | Recipients shall not  | information,         |
|                       | include consumers.*** | available to the     |
|                       |                       | supplier, to allow   |
|                       | ***Consumers shall    | safe use of the      |
|                       | have the right to ask | article including as |
|                       | the producer or       | a minimum, the name  |
|                       | importer for          | of that              |
|                       | information on the    | substance.***        |
|                       | substances present in |                      |
|                       | an article produced   | ***The relevant      |
|                       | or imported by        | information shall be |
|                       | him.***               | provided, free of    |
|                       |                       | charge, within 45    |
|                       | ***Producers or       | days of receipt of   |
|                       | importers shall, on   | the request.***      |
|                       | request and within 15 |                      |
|                       | working days, enable  | \_\_\_\_\_\_         |
|                       | any individual        |                      |
|                       | consumer to obtain,   | The Presidency       |
|                       | free of charge, full  | suggests that an     |
|                       | details of safety and | additional           |
|                       | use information       | definition be        |
|                       | concerning the        | introduced in        |
|                       | substances present in | Article 3:           |
|                       | any article they have |                      |
|                       | produced or           | **(*31 a) Supplier   |
|                       | imported.***          | of an article means  |
|                       |                       | any producer or      |
|                       |                       | importer of an       |
|                       |                       | article, distributor |
|                       |                       | or other actor in    |
|                       |                       | the supply chain     |
|                       |                       | placing an article   |
|                       |                       | on the market.***    |
|                       |                       |                      |
|                       |                       | \_\_\_\_\_\_         |
|                       |                       |                      |
|                       |                       | The Presidency       |
|                       |                       | suggests that the    |
|                       |                       | definition in        |
|                       |                       | Article 3 of         |
|                       |                       | Recipient of an      |
|                       |                       | article be amended   |
|                       |                       | as follows:          |
|                       |                       |                      |
|                       |                       | \(33\) Recipient of  |
|                       |                       | an article means an  |
|                       |                       | industrial or        |
|                       |                       | professional user,   |
|                       |                       | ***or a              |
|                       |                       | distributor***,      |
|                       |                       | being supplied with  |
|                       |                       | an article but does  |
|                       |                       | not include          |
|                       |                       | consumers.           |
|                       |                       |                      |
|                       |                       | \_\_\_\_             |
|                       |                       |                      |
|                       |                       | ***[Article          |
|                       |                       | 137]{.underline}***  |
|                       |                       |                      |
|                       |                       | ***1a (new). By      |
|                       |                       | ...\*, the           |
|                       |                       | Commission shall     |
|                       |                       | carry out a review   |
|                       |                       | to assess whether or |
|                       |                       | not to extend the    |
|                       |                       | scope of Article 32a |
|                       |                       | to cover other       |
|                       |                       | dangerous            |
|                       |                       | substances, taking   |
|                       |                       | into account the     |
|                       |                       | practical experience |
|                       |                       | in implementing that |
|                       |                       | Article. On the      |
|                       |                       | basis of this        |
|                       |                       | review, the          |
|                       |                       | Commission may, if   |
|                       |                       | appropriate, present |
|                       |                       | legislative          |
|                       |                       | proposals to extend  |
|                       |                       | this obligation.***  |
|                       |                       |                      |
|                       |                       | ***\_\_\_\_***       |
|                       |                       |                      |
|                       |                       | ***\*12 years after  |
|                       |                       | the entry into force |
|                       |                       | of this              |
|                       |                       | Regulation***        |
+-----------------------+-----------------------+----------------------+
| Article 76.2 ma       | Amendment 125         | It was agreed to     |
|                       |                       | address this issue   |
| Does not exist.       | ***(ma) establishing  | in Article 122 and   |
|                       | and maintaining a     | in Article 76.2 (see |
|                       | centre of excellence  | Agency part) as      |
|                       | for risk              | follows:             |
|                       | communication;        |                      |
|                       | providing             | *Article 122\        |
|                       | centralised,          | Communication to the |
|                       | coordinated resources | public of            |
|                       | in the area of        | information on risks |
|                       | information on the    | of substances*       |
|                       | safe use of chemical  |                      |
|                       | substances,           | The competent        |
|                       | preparations and      | authorities of the   |
|                       | articles;             | Member States shall  |
|                       | facilitating the      | inform the general   |
|                       | sharing of best       | public about the     |
|                       | practice in the risk  | risks arising from   |
|                       | communication         | substances where     |
|                       | sector.***            | this is considered   |
|                       |                       | necessary for the    |
|                       |                       | protection of human  |
|                       |                       | health or the        |
|                       |                       | environment. The     |
|                       |                       | ~~Commission~~       |
|                       |                       | ***Agency, in        |
|                       |                       | consultation with    |
|                       |                       | competent            |
|                       |                       | authorities and      |
|                       |                       | stakeholders* *and   |
|                       |                       | drawing as           |
|                       |                       | appropriate on       |
|                       |                       | relevant best        |
|                       |                       | practice*,** shall   |
|                       |                       | ~~draw up~~          |
|                       |                       | ~~guidelines~~       |
|                       |                       | ***provide guidance  |
|                       |                       | for the              |
|                       |                       | communication of     |
|                       |                       | information on the   |
|                       |                       | risks and safe use   |
|                       |                       | of chemical          |
|                       |                       | substances, on their |
|                       |                       | own, in preparations |
|                       |                       | or in articles,***   |
|                       |                       | ~~in accordance with |
|                       |                       | the procedure        |
|                       |                       | referred to in       |
|                       |                       | Article 132(3)~~     |
|                       |                       | with a view to       |
|                       |                       | coordinating Member  |
|                       |                       | States in these      |
|                       |                       | activities.          |
+-----------------------+-----------------------+----------------------+

**4. COMITOLOGY**

+-----------------------+-----------------------+----------------------+
| **Council Common      | **EP amendment**      | **Result of the 6th  |
| Position**            |                       | trilogue**           |
+-----------------------+-----------------------+----------------------+
| [Does not             | [No EP                | In accordance with   |
| exist]{.underline}    | a                     | the agreement        |
|                       | mendment]{.underline} | between the legal    |
|                       |                       | services a new       |
|                       |                       | recital on           |
|                       |                       | comitology is        |
|                       |                       | introduced.          |
|                       |                       |                      |
|                       |                       | ***In particular,    |
|                       |                       | power should be      |
|                       |                       | conferred on the     |
|                       |                       | Commission to amend  |
|                       |                       | the Annexes in       |
|                       |                       | certain cases, to    |
|                       |                       | set rules on test    |
|                       |                       | methods, to varying  |
|                       |                       | the percentage of    |
|                       |                       | dossiers selected    |
|                       |                       | for compliance       |
|                       |                       | checking and to      |
|                       |                       | modify the criteria  |
|                       |                       | for their            |
|                       |                       | selection~~, to      |
|                       |                       | determine the        |
|                       |                       | qualifications       |
|                       |                       | required for the     |
|                       |                       | members of the Board |
|                       |                       | of Appeals and the   |
|                       |                       | procedures for these |
|                       |                       | Boards~~ and to set  |
|                       |                       | the criteria         |
|                       |                       | defining what        |
|                       |                       | constitutes adequate |
|                       |                       | justification that   |
|                       |                       | testing is           |
|                       |                       | technically not      |
|                       |                       | possible. Since      |
|                       |                       | these measures are   |
|                       |                       | of general scope and |
|                       |                       | are***               |
|                       |                       |                      |
|                       |                       | ***designed to amend |
|                       |                       | non-essential        |
|                       |                       | elements of this     |
|                       |                       | Regulation or        |
|                       |                       | supplement this      |
|                       |                       | Regulation by the    |
|                       |                       | addition of new      |
|                       |                       | non-essential        |
|                       |                       | elements, they       |
|                       |                       | should be adopted in |
|                       |                       | accordance with the  |
|                       |                       | regulatory procedure |
|                       |                       | with scrutiny        |
|                       |                       | provided for in      |
|                       |                       | Article 5a of        |
|                       |                       | Council Decision     |
|                       |                       | 1999/468/EC.***      |
+-----------------------+-----------------------+----------------------+
| Article 7.8           | *Comitology*          | It was agreed that   |
|                       |                       | Article 132(3)       |
| 8\. Any measures for  | No EP amendment.      | should continue to   |
| the implementation of |                       | apply.               |
| paragraphs 1 to 7     |                       |                      |
| shall be adopted in   |                       |                      |
| accordance with the   |                       |                      |
| procedure referred to |                       |                      |
| in Article 132(3).    |                       |                      |
+-----------------------+-----------------------+----------------------+

+-----------------------+-----------------------+----------------------+
| Article 13.2 subpara  | *Comitology*          | It was agreed that   |
| 1                     |                       | Article              |
|                       | Amendment 44          | ***132(3a)*** in     |
| 2\. Where tests on    |                       | accordance with the  |
| substances are        | 2\. Where tests on    | new Comitology       |
| required to generate  | substances are        | Decision should      |
| information on        | required to generate  | apply.               |
| intrinsic properties  | information on        |                      |
| of substances, they   | intrinsic properties  | In addition the text |
| shall be conducted in | of substances, they   | is redrafted as      |
| accordance with the   | shall be conducted in | follows:             |
| test methods laid     | accordance with the   |                      |
| down in a Commission  | test methods laid     | 2\. Where tests on   |
| Regulation adopted in | down in a Commission  | substances are       |
| accordance with the   | Regulation adopted in | required to generate |
| procedure referred to | accordance with the   | information on       |
| ***in                 | procedure referred to | intrinsic properties |
| Article 132(3**)*,    | in                    | of substances, they  |
| which shall be        | A                     | shall be conducted   |
| revised as            | rticle ***132(3a)***, | in accordance with   |
| appropriate in        | which shall be        | the test methods     |
| particular to refine, | revised as            | laid down in a       |
| reduce or replace     | appropriate in        | Commission           |
| animal testing, or in | particular to refine, | Regulation. ***The   |
| accordance with other | reduce or replace     | Commission shall     |
| international test    | animal testing, or in | adopt this           |
| methods recognised by | accordance with other | Regulation, designed |
| the Commission or the | international test    | to amend the         |
| Agency as being       | methods recognised by | non-essential        |
| appropriate.          | the Commission or the | elements of this     |
|                       | Agency as being       | Regulation by        |
|                       | appropriate.          | supplementing it***  |
|                       |                       | in accordance with   |
|                       |                       | the procedure        |
|                       |                       | referred to in       |
|                       |                       | Article              |
|                       |                       | ***132(3a)***, which |
|                       |                       | shall be revised as  |
|                       |                       | appropriate in       |
|                       |                       | particular to        |
|                       |                       | refine, reduce or    |
|                       |                       | replace animal       |
|                       |                       | testing, or in       |
|                       |                       | accordance with      |
|                       |                       | other international  |
|                       |                       | test methods         |
|                       |                       | recognised by the    |
|                       |                       | Commission or the    |
|                       |                       | Agency as being      |
|                       |                       | appropriate          |
+-----------------------+-----------------------+----------------------+
| Article 40.7          | *Comitology*          | It was agreed that   |
|                       |                       | Article 132(3a) in   |
| 7\. The Commission    | Amendment 70          | accordance with the  |
| may, after consulting |                       | new Comitology       |
| with the Agency, take | 7\. The Commission    | decision should      |
| a decision to vary    | may, after consulting | apply.               |
| the percentage of     | with the Agency, take |                      |
| dossiers selected and | a decision to vary    |                      |
| amend or include      | the percentage of     |                      |
| further criteria in   | dossiers selected and |                      |
| paragraph 5 in        | amend or include      |                      |
| accordance with the   | further criteria in   |                      |
| procedure referred to | paragraph 5 in        |                      |
| in Article            | accordance with the   |                      |
| ***132(3)***.         | procedure referred to |                      |
|                       | in Article            |                      |
|                       | ***132(3a)***.        |                      |
+-----------------------+-----------------------+----------------------+

+-----------------------+-----------------------+----------------------+
| Article 44.3          | *Comitology*          | It was agreed that   |
|                       |                       | Article 132(3)       |
| 3\. In cases where    | No EP amendment.      | should continue to   |
| two or more Member    |                       | apply.               |
| States have expressed |                       |                      |
| an interest in        |                       |                      |
| evaluating the same   |                       |                      |
| substance and they    |                       |                      |
| cannot agree who      |                       |                      |
| should be the         |                       |                      |
| competent authority,  |                       |                      |
| the competent         |                       |                      |
| authority for the     |                       |                      |
| purposes of Articles  |                       |                      |
| 45, 46 and 47 shall   |                       |                      |
| be determined in      |                       |                      |
| accordance with the   |                       |                      |
| following procedure.  |                       |                      |
|                       |                       |                      |
| The Agency shall      |                       |                      |
| refer the matter to   |                       |                      |
| the Member State      |                       |                      |
| Committee, in order   |                       |                      |
| to agree which        |                       |                      |
| authority shall be    |                       |                      |
| the competent         |                       |                      |
| authority, taking     |                       |                      |
| into account the      |                       |                      |
| Member State in which |                       |                      |
| the manufacturer(s)   |                       |                      |
| or importer(s) is     |                       |                      |
| located, the          |                       |                      |
| respective            |                       |                      |
| proportions of total  |                       |                      |
| Community gross       |                       |                      |
| domestic product, the |                       |                      |
| number of substances  |                       |                      |
| already being         |                       |                      |
| evaluated by a Member |                       |                      |
| State and the         |                       |                      |
| expertise available.  |                       |                      |
|                       |                       |                      |
| If, within 60 days of |                       |                      |
| the referral, the     |                       |                      |
| Member State          |                       |                      |
| Committee reaches     |                       |                      |
| unanimous agreement,  |                       |                      |
| the Member States     |                       |                      |
| concerned shall adopt |                       |                      |
| substances for        |                       |                      |
| evaluation            |                       |                      |
| accordingly.          |                       |                      |
|                       |                       |                      |
| If the Member State   |                       |                      |
| Committee fails to    |                       |                      |
| reach a unanimous     |                       |                      |
| agreement, the Agency |                       |                      |
| shall submit the      |                       |                      |
| conflicting opinions  |                       |                      |
| to the Commission,    |                       |                      |
| which shall decide    |                       |                      |
| which authority shall |                       |                      |
| be the competent      |                       |                      |
| authority, in         |                       |                      |
| accordance with the   |                       |                      |
| procedure referred to |                       |                      |
| in                    |                       |                      |
| Article ***132(3)***, |                       |                      |
| and the Member States |                       |                      |
| concerned shall adopt |                       |                      |
| substances for        |                       |                      |
| evaluation            |                       |                      |
| accordingly.          |                       |                      |
+-----------------------+-----------------------+----------------------+
| Article 46.2          | *Comitology*          | It was agreed that   |
|                       |                       | Article 132(3)       |
| 2\. In order to       | Amendment 71          | should continue to   |
| ensure a harmonised   |                       | apply.               |
| approach to requests  | 2\. In order to       |                      |
| for further           | ensure a harmonised   |                      |
| information, the      | approach to requests  |                      |
| Agency shall monitor  | for further           |                      |
| draft decisions under | information, the      |                      |
| Article 45 and shall  | Agency shall monitor  |                      |
| develop criteria and  | draft decisions under |                      |
| priorities. Where     | Article 45 and shall  |                      |
| appropriate,          | develop criteria and  |                      |
| implementing measures | priorities. Where     |                      |
| shall be adopted in   | appropriate,          |                      |
| accordance with the   | implementing measures |                      |
| procedure referred to | shall be adopted in   |                      |
| in                    | accordance with the   |                      |
| Article ***132(3)***. | procedure referred to |                      |
|                       | in                    |                      |
|                       | A                     |                      |
|                       | rticle ***132(3a)***. |                      |
+-----------------------+-----------------------+----------------------+
| Article 50.7          | *Comitology*          | It was agreed that   |
|                       |                       | Article 132(3)       |
| 7\. If the Member     | No EP amendment.      | should continue to   |
| State Committee fails |                       | apply.               |
| to reach unanimous    |                       |                      |
| agreement, the        |                       |                      |
| Commission shall      |                       |                      |
| prepare a draft       |                       |                      |
| decision to be taken  |                       |                      |
| in accordance with    |                       |                      |
| the procedure         |                       |                      |
| referred to **in      |                       |                      |
| Article 132(3).**     |                       |                      |
+-----------------------+-----------------------+----------------------+
| Article 57 title and  | *Comitology*          | It was agreed that   |
| 57.1 introductory     |                       | Article 132(3a) in   |
| part                  | Amendment 81          | accordance with the  |
|                       |                       | new Comitology       |
| Article 57            | Article 57            | decision should      |
|                       |                       | apply.               |
| Inclusion of          | Inclusion of          |                      |
| substances in Annex   | substances in Annex   |                      |
| ***XIV***             | ***XIV(b)***          |                      |
|                       |                       |                      |
| 1\. Whenever a        | 1\. Whenever a        |                      |
| decision is taken to  | decision is taken to  |                      |
| include in Annex      | include in Annex      |                      |
| ***XIV*** substances  | ***XIV(b)***          |                      |
| referred to in        | substances referred   |                      |
| Article 56, such a    | to in Article 56,     |                      |
| decision shall be     | such a decision shall |                      |
| taken in accordance   | be taken in           |                      |
| with the procedure    | accordance with the   |                      |
| referred to in        | procedure referred to |                      |
| Article ***132(3)***. | in Article            |                      |
| It shall specify for  | ***132(3a).*** It     |                      |
| each substance:       | shall specify for     |                      |
|                       | each substance:       |                      |
+-----------------------+-----------------------+----------------------+
| Article 57.8          | *Comitology*          | It was agreed that   |
|                       |                       | Article 132(3a) in   |
| 8\. Substances which  | Amendment 92          | accordance with the  |
| as a result of new    |                       | new Comitology       |
| information no longer | 8\. Substances which  | Decision should      |
| meet the criteria of  | as a result of new    | apply.               |
| Article 56 shall be   | information no longer |                      |
| removed from Annex    | meet the criteria of  |                      |
| XIV in accordance     | Article 56 shall be   |                      |
| with the procedure    | removed from Annex    |                      |
| referred to in        | XIV in accordance     |                      |
| Article ***132(3)***. | with the procedure    |                      |
|                       | referred to in        |                      |
|                       | A                     |                      |
|                       | rticle ***132(3a)***. |                      |
+-----------------------+-----------------------+----------------------+

+-----------------------+-----------------------+----------------------+
| Article 58.8 and 58.9 | *Including            | It was agreed that   |
|                       | Comitology*           | the wording in the   |
| [Only 58.9 relevant   |                       | Common Position      |
| for                   | Amendment 96          | should be retained   |
| co                    |                       | in the entire        |
| mitology]{.underline} | \[8. If, within       | article.             |
|                       | 30 days of the        |                      |
| \[8. If, within       | referral, the Member  | It was agreed that   |
| 30 days of the        | State Committee       | Article 132(3)       |
| referral, the Member  | reaches a             | should continue to   |
| State Committee       | ***qualified          | apply.               |
| reaches a             | majority*** agreement |                      |
| ***unanimous***       | ***that the substance |                      |
| agreement on the      | satisfies the         |                      |
| identification, the   | criteria for          |                      |
| Agency shall          | authorisation and     |                      |
| ***include the        | should be included in |                      |
| substance in the list | Annex XIV(b),*** the  |                      |
| referred to in        | Agency shall***,      |                      |
| paragraph 1. The      | within 15 working     |                      |
| Agency may include    | days, recommend to    |                      |
| that substance in its | the Commission that   |                      |
| recommendations       | the substance be      |                      |
| under***              | included in Annex     |                      |
| Article 57(3). \]     | XIV(b), as provided   |                      |
|                       | for in***             |                      |
| 9\. If the Member     | Article 57(3).\]      |                      |
| State Committee fails |                       |                      |
| to reach a unanimous  | 9\. If the Member     |                      |
| agreement, the        | State Committee fails |                      |
| Commission shall      | to reach a            |                      |
| prepare a draft       | ***qualified          |                      |
| proposal on the       | majority***           |                      |
| identification of the | agreement, ***it      |                      |
| substance within      | shall adopt an        |                      |
| three months of       | opinion within        |                      |
| receipt of the        | 30 days of the        |                      |
| opinion of the Member | referral. The Agency  |                      |
| State Committee. A    | shall transmit that   |                      |
| final decision on the | opinion to the        |                      |
| identification of the | Commission within 15  |                      |
| substance shall be    | working days,         |                      |
| taken in accordance   | including information |                      |
| with the procedure    | on any minority view  |                      |
| referred to in        | within the            |                      |
| Article ***132(3)***. | Committee.*** A final |                      |
|                       | decision on the       |                      |
|                       | identification of the |                      |
|                       | substance shall be    |                      |
|                       | taken in accordance   |                      |
|                       | with the procedure    |                      |
|                       | referred to in        |                      |
|                       | Article               |                      |
|                       | ***132(3a)***.        |                      |
+-----------------------+-----------------------+----------------------+
| Article 63.8*\        | *Comitology*          | It was agreed that   |
| *                     |                       | Article ***132(3)*** |
|                       | Amendment 113         | should apply, in     |
| 8\. The Commission    |                       | addition a new       |
| shall prepare a draft | 8\. The Commission    | recital is added:.   |
| authorisation         | shall prepare a draft |                      |
| decision within       | authorisation         | ***(zz) It is        |
| three months of       | decision within       | convenient that      |
| receipt of the        | three months of       | final decisions      |
| opinions from the     | receipt of the        | granting or refusing |
| Agency. A final       | opinions from the     | the authorisations   |
| decision granting or  | Agency. A final       | be adopted by the    |
| refusing the          | decision granting or  | Commission pursuant  |
| authorisation shall   | refusing the          | to a regulatory      |
| be taken in           | authorisation shall   | procedure in order   |
| accordance with the   | be taken in           | to allow for an      |
| procedure referred to | accordance with the   | examination of their |
| in                    | procedure referred to | wider implications   |
| Article ***132(2)***. | in                    | within the Member    |
|                       | A                     | States and to more   |
|                       | rticle ***132(3a)***. | closely associate    |
|                       |                       | these.***            |
+-----------------------+-----------------------+----------------------+

+-----------------------+-----------------------+----------------------+
| Article 67.1 subpara  | *Comitology*          | It was agreed that   |
| 1                     |                       | the wording in the   |
|                       | Amendment 117         | Common Position      |
| 1\. When there is an  |                       | should be retained   |
| unacceptable risk to  | 1\. When there is an  | for the entire       |
| ***human health or    | unacceptable risk to  | article apart from   |
| the environment***,   | ***the environment or | the Comitology       |
| arising from the      | to human health,      | reference.           |
| manufacture, use or   | including that of     |                      |
| placing on the market | vulnerable            | It was agreed that   |
| of substances, which  | populations and       | Article              |
| needs to be addressed | citizens exposed      | ***132(3a)*** in     |
| on a Community-wide   | early in life or      | accordance with the  |
| basis, Annex XVII     | continuously to       | new Comitology       |
| shall be amended in   | mixtures of           | Decision should      |
| accordance with the   | pollutants***,        | apply.               |
| procedure referred to | arising from the      |                      |
| in                    | manufacture, use or   |                      |
| Article ***132(3)***  | placing on the market |                      |
| by adopting new       | of substances, which  |                      |
| restrictions, or      | needs to be addressed |                      |
| amending current      | on a Community-wide   |                      |
| restrictions in       | basis, Annex XVII     |                      |
| Annex XVII, for the   | shall be amended in   |                      |
| manufacture, use or   | accordance with the   |                      |
| placing on the market | procedure referred to |                      |
| of substances on      | in                    |                      |
| their own, in         | Article ***132(3a)*** |                      |
| preparations or in    | by adopting new       |                      |
| articles, pursuant to | restrictions, or      |                      |
| the procedure set out | amending current      |                      |
| in Articles 68 to 72. | restrictions in       |                      |
| Any such decision     | Annex XVII, for the   |                      |
| shall take into       | manufacture, use or   |                      |
| account the           | placing on the market |                      |
| socio-economic impact | of substances on      |                      |
| of the restriction,   | their own, in         |                      |
| including the         | preparations or in    |                      |
| availability of       | articles, pursuant to |                      |
| alternatives.         | the procedure set out |                      |
|                       | in Articles 68 to 72. |                      |
|                       | Any such decision     |                      |
|                       | shall take into       |                      |
|                       | account the           |                      |
|                       | socio-economic impact |                      |
|                       | of the restriction,   |                      |
|                       | including the         |                      |
|                       | availability of       |                      |
|                       | alternatives.         |                      |
+-----------------------+-----------------------+----------------------+
| Article 67.2          | *Comitology*          | It was agreed that   |
|                       |                       | Article              |
| 2\. For a substance   | Amendment 118         | ***132(3a***) in     |
| on its own, in a      |                       | accordance with the  |
| preparation or in an  | 2\. For a substance   | new Comitology       |
| article which meets   | on its own, in a      | Decision should      |
| the criteria for      | preparation or in an  | apply.               |
| classification as     | article which meets   |                      |
| carcinogenic,         | the criteria for      |                      |
| mutagenic or toxic to | classification as     |                      |
| reproduction,         | carcinogenic,         |                      |
| category 1 or 2, and  | mutagenic or toxic to |                      |
| could be used by      | reproduction,         |                      |
| consumers and for     | category 1 or 2, and  |                      |
| which restrictions to | could be used by      |                      |
| consumer use are      | consumers and for     |                      |
| proposed by the       | which restrictions to |                      |
| Commission,           | consumer use are      |                      |
| Annex XVII shall be   | proposed by the       |                      |
| amended in accordance | Commission,           |                      |
| with the procedure    | Annex XVII shall be   |                      |
| referred to in        | amended in accordance |                      |
| Article ***132(3)***. | with the procedure    |                      |
| Articles 68 to 72     | referred to in        |                      |
| shall not apply.      | A                     |                      |
|                       | rticle ***132(3a)***. |                      |
|                       | Articles 68 to 72     |                      |
|                       | shall not apply.      |                      |
+-----------------------+-----------------------+----------------------+

+-----------------------+-----------------------+----------------------+
| Article 68.5          | *Comitology*          | It was agreed that   |
|                       |                       | Article 132(2)       |
| 5\. The Agency shall  | No EP Amendment.      | should continue to   |
| maintain a list of    |                       | apply.               |
| substances for which  |                       |                      |
| a dossier conforming  |                       |                      |
| to the requirements   |                       |                      |
| of Annex XV is        |                       |                      |
| planned or underway   |                       |                      |
| by either the Agency  |                       |                      |
| or a Member State for |                       |                      |
| the purposes of a     |                       |                      |
| proposed restriction. |                       |                      |
| If a substance is on  |                       |                      |
| the list, no other    |                       |                      |
| such dossier shall be |                       |                      |
| prepared. If it is    |                       |                      |
| proposed by either a  |                       |                      |
| Member State or the   |                       |                      |
| Agency that an        |                       |                      |
| existing restriction  |                       |                      |
| listed in Annex XVII  |                       |                      |
| should be re‑examined |                       |                      |
| a decision on whether |                       |                      |
| to do so shall be     |                       |                      |
| taken in accordance   |                       |                      |
| with the procedure    |                       |                      |
| referred to in        |                       |                      |
| Article ***132(2)***  |                       |                      |
| based on evidence     |                       |                      |
| presented by the      |                       |                      |
| Member State or the   |                       |                      |
| Agency.               |                       |                      |
+-----------------------+-----------------------+----------------------+
| Article 72            | *Comitology*          | It was agreed that   |
|                       |                       | the wording of the   |
| 1\. If the conditions | Amendment 120         | Common Position      |
| laid down in          |                       | should be retained   |
| Article 67 are        | 1\. ***Where a        | but that Article     |
| fulfilled, the        | substance is already  | ***132(3a)*** in     |
| Commission shall      | regulated in Annex    | accordance with the  |
| prepare a draft       | XVII, and*** if the   | new Comitology       |
| amendment to          | conditions laid down  | Decision should      |
| Annex XVII, within    | in Article 67 are     | apply.               |
| three months of       | fulfilled, the        |                      |
| receipt of the        | Commission shall      |                      |
| opinion of the        | prepare a draft       |                      |
| Committee for         | amendment to          |                      |
| Socio-economic        | Annex XVII, within    |                      |
| Analysis or by the    | three months of       |                      |
| end of the deadline   | receipt of the        |                      |
| established under     | opinion of the        |                      |
| Article 70 if that    | Committee for         |                      |
| Committee does not    | Socio-economic        |                      |
| form an opinion,      | Analysis or by the    |                      |
| whichever is the      | end of the deadline   |                      |
| earlier.              | established under     |                      |
|                       | Article 70 if that    |                      |
| Where the draft       | Committee does not    |                      |
| amendment diverges    | form an opinion,      |                      |
| from the original     | whichever is the      |                      |
| proposal or if it     | earlier.              |                      |
| does not take the     |                       |                      |
| opinions from the     | Where the draft       |                      |
| Agency into account,  | amendment diverges    |                      |
| the Commission shall  | from the original     |                      |
| annex a detailed      | proposal or if it     |                      |
| explanation of the    | does not take the     |                      |
| reasons for the       | opinions from the     |                      |
| differences.          | Agency into account,  |                      |
|                       | the Commission shall  |                      |
| 2\. A final decision  | annex a detailed      |                      |
| shall be taken in     | explanation of the    |                      |
| accordance with the   | reasons for the       |                      |
| procedure referred to | differences.          |                      |
| in                    |                       |                      |
| Ar                    | 2\. A final decision  |                      |
| ticle** *132(3****)*. | shall be taken in     |                      |
| The Commission shall  | accordance with the   |                      |
| send the draft        | procedure referred to |                      |
| amendment to the      | in                    |                      |
| Member States at      | A                     |                      |
| least 45 days before  | rticle ***132(3a)***. |                      |
| voting.               | The Commission shall  |                      |
|                       | send the draft        |                      |
|                       | amendment to the      |                      |
|                       | Member States at      |                      |
|                       | least 45 days before  |                      |
|                       | voting.               |                      |
|                       |                       |                      |
|                       | ***2a. Where a        |                      |
|                       | substance has not     |                      |
|                       | been regulated before |                      |
|                       | in Annex XVII, the    |                      |
|                       | Commission shall      |                      |
|                       | submit a proposal to  |                      |
|                       | the European          |                      |
|                       | Parliament and the    |                      |
|                       | Council to amend      |                      |
|                       | Annex XVII within the |                      |
|                       | time limit specified  |                      |
|                       | in paragraph 1.***    |                      |
+-----------------------+-----------------------+----------------------+
| Article 73.1          | *Comitology*          | It was agreed that   |
|                       |                       | Article 132(3)       |
| 1\. The fees that are | No EP amendment.      | should continue to   |
| required according to |                       | apply.               |
| Article 6(4), Article |                       |                      |
| 7(1) and (5), Article |                       |                      |
| 9(2), Article 11(4),  |                       |                      |
| Article 17(2),        |                       |                      |
| Article 18(2),        |                       |                      |
| Article 19(3),        |                       |                      |
| Article 22(5),        |                       |                      |
| Article 61(7) and     |                       |                      |
| Article 91(3) shall   |                       |                      |
| be specified in a     |                       |                      |
| Commission Regulation |                       |                      |
| adopted in accordance |                       |                      |
| with the procedure    |                       |                      |
| referred to **in      |                       |                      |
| Article 132(3)** by   |                       |                      |
| ...\*.                |                       |                      |
|                       |                       |                      |
| \_\_\_\_\_            |                       |                      |
|                       |                       |                      |
| \* One year after     |                       |                      |
| entry into force of   |                       |                      |
| this Regulation.      |                       |                      |
+-----------------------+-----------------------+----------------------+
| Article 88.4          | *Comitology*          | ***It was agreed     |
|                       |                       | that Article 132(3)  |
| 4\. The               | Amendment 144         | should continue to   |
| qualifications        |                       | apply.***            |
| required for the      | 4\. The               |                      |
| members of the Board  | qualifications        |                      |
| of Appeal shall be    | required for the      |                      |
| determined by the     | members of the Board  |                      |
| Commission in         | of Appeal shall be    |                      |
| accordance with the   | determined by the     |                      |
| procedure referred to | Commission in         |                      |
| in                    | accordance with the   |                      |
| Article ***132(3)***. | procedure referred to |                      |
|                       | in                    |                      |
|                       | A                     |                      |
|                       | rticle ***132(3a)***. |                      |
+-----------------------+-----------------------+----------------------+
| Article 92.4*\        | *Comitology*          | ***It was agreed     |
| *                     |                       | that Article 132(3)  |
|                       | Amendment 147         | should continue to   |
| 4\. The procedures    |                       | apply.***            |
| for the Board of      | 4\. The procedures    |                      |
| Appeal shall be       | for the Board of      |                      |
| determined by the     | Appeal shall be       |                      |
| Commission in         | determined by the     |                      |
| accordance with the   | Commission in         |                      |
| procedure referred to | accordance with the   |                      |
| in Article            | procedure referred to |                      |
| ***132(3)***.         | in Article            |                      |
|                       | ***132(3a)***.        |                      |
+-----------------------+-----------------------+----------------------+

+-----------------------+-----------------------+----------------------+
| Article 122           | *Comitology*          | It was agreed to     |
|                       |                       | amend Article 122 in |
| The competent         | No EP amendment on    | order to respond to  |
| authorities of the    | Comitology.           | Amendment 125        |
| Member States shall   |                       | concerning risk      |
| inform the general    |                       | communication (see   |
| public about the      |                       | Article 76.2).       |
| risks arising from    |                       |                      |
| substances where this |                       | The question on      |
| is considered         |                       | comitology is no     |
| necessary for the     |                       | longer relevant due  |
| protection of human   |                       | to the changes       |
| health or the         |                       | agreed to in Article |
| environment. The      |                       | 122.                 |
| Commission shall draw |                       |                      |
| up guidelines in      |                       |                      |
| accordance with the   |                       |                      |
| procedure referred to |                       |                      |
| **in Article 132(3**) |                       |                      |
| with a view to        |                       |                      |
| coordinating Member   |                       |                      |
| States in these       |                       |                      |
| activities.           |                       |                      |
+-----------------------+-----------------------+----------------------+
| Article 128.2         | *Comitology*          | It was agreed that   |
|                       |                       | Article 132(3)       |
| 2\. The Commission    | No EP amendment.      | should continue to   |
| shall take a decision |                       | apply.               |
| in accordance with    |                       |                      |
| the procedure         |                       |                      |
| referred to in        |                       |                      |
| **Article 132(3**)    |                       |                      |
| within 60 days of     |                       |                      |
| receipt of the        |                       |                      |
| information from the  |                       |                      |
| Member State. This    |                       |                      |
| decision shall        |                       |                      |
| either:               |                       |                      |
|                       |                       |                      |
| \(a\) authorise the   |                       |                      |
| provisional measure   |                       |                      |
| for a time period     |                       |                      |
| defined in the        |                       |                      |
| decision; or          |                       |                      |
|                       |                       |                      |
| (b)require the Member |                       |                      |
| State to revoke the   |                       |                      |
| provisional measure.  |                       |                      |
+-----------------------+-----------------------+----------------------+
| Article 130           | *Comitology*          | It was agreed that   |
|                       |                       | Article              |
| The Annexes may be    | Amendment 155         | ***132(3a)*** in     |
| amended in accordance |                       | accordance with the  |
| with the procedure    | The Annexes may be    | new Comitology       |
| referred to in        | amended in accordance | Decision should      |
| Article ***132(3)***. | with the procedure    | apply.               |
|                       | referred to in        |                      |
|                       | Article               |                      |
|                       | ***132(3a)***.        |                      |
+-----------------------+-----------------------+----------------------+

+-----------------------+-----------------------+----------------------+
| Article 131           | *Comitology*          | It was agreed that   |
|                       |                       | the wording of the   |
| ***The measures       | Amendment 156         | Common Position      |
| necessary*** for the  |                       | should be redrafted  |
| efficient             | ***Where,*** for the  | as follows**:**      |
| implementation of     | efficient             |                      |
| this Regulation shall | implementation of     | The measures         |
| be adopted in         | this Regulation***,   | necessary ***to put  |
| accordance with the   | it proves             | into effect          |
| procedure referred to | necessary*** ***to    | efficiently the      |
| in Article 132(3).    | adopt measures for    | provisions*** of     |
|                       | which the powers have | this Regulation      |
|                       | not been provided     | shall be adopted in  |
|                       | elsewhere in this     | accordance wit the   |
|                       | Regulation, these     | procedure referred   |
|                       | measures*** shall be  | to in Article 132    |
|                       | adopted:              | (3).                 |
|                       |                       |                      |
|                       | ***(a)*** in          |                      |
|                       | accordance with the   |                      |
|                       | procedure referred to |                      |
|                       | in Article 132(3),    |                      |
|                       | ***when the measures  |                      |
|                       | to be adopted are     |                      |
|                       | measures of general   |                      |
|                       | scope designed to     |                      |
|                       | apply essential       |                      |
|                       | provisions of this    |                      |
|                       | Regulation;***        |                      |
|                       |                       |                      |
|                       | ***(b)*** ***in       |                      |
|                       | accordance with the   |                      |
|                       | procedure referred to |                      |
|                       | in Article            |                      |
|                       | 132(3a),*** ***when   |                      |
|                       | the measures to be    |                      |
|                       | adopted are measures  |                      |
|                       | of general scope      |                      |
|                       | designed to amend     |                      |
|                       | non-essential         |                      |
|                       | elements of this      |                      |
|                       | Regulation.***        |                      |
+-----------------------+-----------------------+----------------------+
| Article 132.3 a       | Amendment 157         | It was agreed that   |
|                       |                       | the following        |
| Does not exist.       | ***3a. Where          | paragraph 3a be      |
|                       | reference is made to  | introduced in        |
|                       | this paragraph,       | Article 132:         |
|                       | Articles 5a and 7 of  |                      |
|                       | Decision 1999/468/EC  | ***3a. Where         |
|                       | as amended by         | reference is made to |
|                       | Decision 2006/512/EC  | this paragraph,      |
|                       | shall apply.***       | Articles 5a,         |
|                       |                       | paragraphs 1 to      |
|                       |                       | 4,and 7 of Decision  |
|                       |                       | 1999/468/EC shall    |
|                       |                       | apply, having regard |
|                       |                       | to the provisions of |
|                       |                       | Article 8            |
|                       |                       | thereof.***          |
+-----------------------+-----------------------+----------------------+
| Article 137.4         | *Comitology*          | It was agreed to     |
|                       |                       | redraft the Article  |
| 4\. The Commission    | Amendment 160         | as follows:          |
| shall carry out a     |                       |                      |
| review of Annexes     | 4\. The Commission    | 4\. The Commission   |
| ***I***, IV and V by  | shall carry out a     | shall carry out a    |
| ..., with a view to   | review of Annexes IV  | review of Annexes I, |
| proposing amendments, | and V by ...\*, with  | IV and V by ...,     |
| if appropriate, to    | a view to proposing   | with a view to       |
| them in accordance    | amendments, if        | proposing            |
| with the procedure    | appropriate, to them  | amendments, if       |
| referred to in        | in accordance with    | appropriate, to them |
| Article ***132(3)***. | the procedure         | in accordance with   |
|                       | referred to in        | the procedure        |
|                       | A                     | referred to in       |
|                       | rticle ***132(3a)***. | Article ***130.***   |
+-----------------------+-----------------------+----------------------+

+-----------------------+-----------------------+----------------------+
| ANNEX XI, POINT 3.3   | *Comitology*          | It was agreed that   |
|                       |                       | Article 132(3a) in   |
| 3.3. The Commission   | Amendment 170         | accordance with the  |
| shall adopt           |                       | new Comitology       |
| ***criteria defining  | 3.3. The Commission   | Decision should      |
| what constitutes      | shall adopt criteria  | apply and to redraft |
| adequate              | defining what         | as follows:          |
| justification under   | constitutes adequate  |                      |
| Section 2 in***       | justification under   | 3.3. The Commission  |
| accordance with the   | Section 2 in          | shall adopt ***the   |
| procedure referred to | accordance with the   | measures designed to |
| in Article            | procedure referred to | amend non-essential  |
| ***132(3)*** by       | in Article            | elements of this     |
| ...\*.                | ***132(3a)*** by      | Regulation by        |
|                       | ...\*.                | supplementing it***, |
|                       |                       | in accordance with   |
|                       |                       | the procedure        |
|                       |                       | referred to in       |
|                       |                       | Article              |
|                       |                       | ***132(3a)**, **to   |
|                       |                       | set the criteria     |
|                       |                       | defining what        |
|                       |                       | constitutes adequate |
|                       |                       | justification under  |
|                       |                       | Section 3.2          |
|                       |                       | by***\...\*          |
|                       |                       |                      |
|                       |                       | \* 18 months after   |
|                       |                       | entry force of this  |
|                       |                       | Regulation.          |
+-----------------------+-----------------------+----------------------+

**5. AGENCY**

+-----------------------+-----------------------+----------------------+
| **Council Common      | **EP amendment**      | **Result of the 6th  |
| Position**            |                       | trilogue**           |
+-----------------------+-----------------------+----------------------+
| Article 7.7 a         | Amendments 39         | It was agreed to     |
|                       |                       | introduce a specific |
| Does not exist.       | ***7a. The Agency     | reference to Article |
|                       | shall provide         | 7 in Article 76.2    |
|                       | guidelines to help    | (f) as follows:      |
|                       | the producers and     |                      |
|                       | importers of articles | 2\. The Secretariat  |
|                       | as well as the        | shall undertake the  |
|                       | competent             | following tasks:     |
|                       | authorities.***       |                      |
|                       |                       | \(e\) ...            |
|                       |                       |                      |
|                       |                       | \(f\) providing      |
|                       |                       | technical and        |
|                       |                       | scientific guidance  |
|                       |                       | and tools where      |
|                       |                       | appropriate for the  |
|                       |                       | operation of this    |
|                       |                       | Regulation in        |
|                       |                       | particular to assist |
|                       |                       | the development of   |
|                       |                       | chemical safety      |
|                       |                       | reports (in          |
|                       |                       | accordance with      |
|                       |                       | Article 14, Article  |
|                       |                       | 31(1) and Article    |
|                       |                       | 36(4)), application  |
|                       |                       | of                   |
|                       |                       | Article 10(a)(viii), |
|                       |                       | Article 11(3) and    |
|                       |                       | Article 19(2) by     |
|                       |                       | industry and         |
|                       |                       | especially by SMEs,  |
|                       |                       | ***and technical and |
|                       |                       | scientific guidance  |
|                       |                       | for the application  |
|                       |                       | of Article 7 by      |
|                       |                       | producers and        |
|                       |                       | importers of         |
|                       |                       | articles;***         |
|                       |                       |                      |
|                       |                       | \(g\) ...            |
+-----------------------+-----------------------+----------------------+
| Article 75.1 da       | Amendment 122         | It was agreed to     |
|                       |                       | address this concern |
| Does not exist.       | ***(da) a Committee   | in the context of    |
|                       | for Alternative Test  | amendment 45         |
|                       | Methods, which shall  | (Article 13.2.1.a).  |
|                       | be responsible for    |                      |
|                       | developing and        |                      |
|                       | implementing an       |                      |
|                       | integrated strategy   |                      |
|                       | to speed up the       |                      |
|                       | development,          |                      |
|                       | validation and legal  |                      |
|                       | acceptance of         |                      |
|                       | non-animal test       |                      |
|                       | methods, and to       |                      |
|                       | ensure their use in   |                      |
|                       | intelligent stepwise  |                      |
|                       | risk assessment to    |                      |
|                       | meet the requirements |                      |
|                       | of this Regulation.   |                      |
|                       | The Committee shall   |                      |
|                       | be responsible for    |                      |
|                       | allocating funding    |                      |
|                       | for alternative test  |                      |
|                       | methods provided      |                      |
|                       | through the           |                      |
|                       | registration fee. The |                      |
|                       | Committee shall       |                      |
|                       | consist of experts    |                      |
|                       | from the European     |                      |
|                       | Centre for the        |                      |
|                       | Validation of         |                      |
|                       | Alternative Methods,  |                      |
|                       | animal welfare        |                      |
|                       | organisations and     |                      |
|                       | other relevant        |                      |
|                       | stakeholders.***      |                      |
|                       |                       |                      |
|                       | ***Every year the     |                      |
|                       | Committee shall       |                      |
|                       | produce a report to   |                      |
|                       | be presented by the   |                      |
|                       | Agency to the         |                      |
|                       | European Parliament   |                      |
|                       | and the Council on    |                      |
|                       | the progress made on  |                      |
|                       | the development,      |                      |
|                       | validation and legal  |                      |
|                       | acceptance of         |                      |
|                       | non-animal test       |                      |
|                       | methods, the use of   |                      |
|                       | such methods in       |                      |
|                       | intelligent stepwise  |                      |
|                       | risk assessment to    |                      |
|                       | meet the requirements |                      |
|                       | of this Regulation,   |                      |
|                       | and the amount and    |                      |
|                       | distribution of       |                      |
|                       | funding for           |                      |
|                       | alternative test      |                      |
|                       | methods.***           |                      |
+-----------------------+-----------------------+----------------------+
| Article 76.2 ma       | Amendment 125         | It was agreed to     |
|                       |                       | introduce the        |
| Does not exist.       | ***(ma) establishing  | following text in a  |
|                       | and maintaining a     | new sub-paragraph    |
|                       | centre of excellence  | (ga) as part of the  |
|                       | for risk              | response to          |
|                       | communication;        | Amendment 125. (See  |
|                       | providing             | also Amendment to    |
|                       | centralised,          | Article 122 in       |
|                       | coordinated resources | section 3.           |
|                       | in the area of        | Communication of     |
|                       | information on the    | Information)         |
|                       | safe use of chemical  |                      |
|                       | substances,           | \(g\) ...            |
|                       | preparations and      |                      |
|                       | articles;             | ***(ga) providing    |
|                       | facilitating the      | guidance to          |
|                       | sharing of best       | stakeholders         |
|                       | practice in the risk  | including Member     |
|                       | communication         | State competent      |
|                       | sector.***            | authorities on       |
|                       |                       | communication to the |
|                       |                       | public of            |
|                       |                       | information on the   |
|                       |                       | risks and safe use   |
|                       |                       | of substances, on    |
|                       |                       | their own, in        |
|                       |                       | preparations or in   |
|                       |                       | articles.***         |
|                       |                       |                      |
|                       |                       | \(h\) ...            |
+-----------------------+-----------------------+----------------------+
| Article 76.3 c        | Amendment 126         | It was agreed to     |
|                       |                       | address this issue   |
| \(c\) at the          | \(c\) at the          | as follows:          |
| Commission's request, | Commission's ***or    |                      |
| drawing up an opinion | the European          | \(c\) at the         |
| on any other aspects  | Parliament's***       | ***Executive         |
| concerning the safety | request, drawing up   | Director\'s***       |
| of substances on      | an opinion on any     | request, drawing up  |
| their own, in         | other aspects         | an opinion on any    |
| preparations or in    | concerning the safety | other aspects        |
| articles.             | of substances on      | concerning the       |
|                       | their own, in         | safety of substances |
|                       | preparations or in    | on their own, in     |
|                       | articles.             | preparations or in   |
|                       |                       | articles.            |
|                       |                       |                      |
|                       |                       | As a consequence It  |
|                       |                       | was agreed to amend  |
|                       |                       | point (b) of the     |
|                       |                       | same Article as      |
|                       |                       | follows:             |
|                       |                       |                      |
|                       |                       | \(b\) at the         |
|                       |                       | ***Executive         |
|                       |                       | Director\'s***       |
|                       |                       | request, providing   |
|                       |                       | technical and        |
|                       |                       | scientific support   |
|                       |                       | ...                  |
+-----------------------+-----------------------+----------------------+

+-----------------------+-----------------------+----------------------+
| Article 76.4 d        | > Amendment 127       | It was agreed to     |
|                       | >                     | address the concern  |
| \(d\) identifying     | > \(d\) identifying   | behind this          |
| enforcement           | > enforcement         | Amendment in Article |
| strategies, as well   | > strategies, as well | 76.4 (g)             |
| as best practice in   | > as best practice in |                      |
| enforcement;          | > enforcement***,     | \(g\) liaising with  |
|                       | > taking particular   | industry***, taking  |
|                       | > account of the      | particular account   |
|                       | > specific problems   | of the specific      |
|                       | > for SMEs***;        | needs of             |
|                       |                       | SM                   |
|                       |                       | Es***[,]{.underline} |
|                       |                       | and other            |
|                       |                       | stakeholders,        |
|                       |                       | including relevant   |
|                       |                       | international        |
|                       |                       | organisations, as    |
|                       |                       | necessary.           |
+-----------------------+-----------------------+----------------------+
| Article 78.1          | Amendment 129         | It was agreed that   |
|                       |                       | the wording be       |
| 1\. The Management    | 1\. The Management    | modified as follows: |
| Board shall be        | Board shall be        |                      |
| composed of one       | composed of one       | 1\. The Management   |
| representative from   | representative from   | Board shall be       |
| each Member State and | each Member           | composed of one      |
| a maximum of six      | State***,*** and a    | representative from  |
| representatives       | maximum of six        | each Member State    |
| appointed by the      | representatives       | and a maximum of six |
| Commission,           | appointed by the      | representatives      |
|                       | Commission ***and two | appointed by the     |
| including three       | representatives       | Commission,          |
| individuals from      | nominated by the      |                      |
| interested parties    | European              | including three      |
| without voting        | Parliament.***        | individuals from     |
| rights.               |                       | interested parties   |
|                       | ***In addition, four  | without voting       |
| Each Member State     | representatives of*** | rights, ***and in    |
| shall nominate a      | interested parties    | addition two         |
| member to the         | ***(industry and      | independent persons  |
| Management Board. The | consumer, worker and  | appointed by the     |
| members thus          | environmental         | European             |
| nominated shall be    | protection            | Parliament***.       |
| appointed by the      | organisations) shall  |                      |
| Council.              | be nominated by the   | Each Member State    |
|                       | Commission as members | shall nominate a     |
|                       | of the Management     | member to the        |
|                       | Board*** without      | Management Board.    |
|                       | voting rights***.***  | The members thus     |
|                       |                       | nominated shall be   |
|                       | ***The members of the | appointed by the     |
|                       | Management Board      | Council.             |
|                       | shall be nominated in |                      |
|                       | such a way as to      |                      |
|                       | ensure the highest    |                      |
|                       | levels of competence, |                      |
|                       | a wide range of       |                      |
|                       | relevant specialist   |                      |
|                       | knowledge and         |                      |
|                       | (without prejudice to |                      |
|                       | such characteristics) |                      |
|                       | the broadest possible |                      |
|                       | geographical          |                      |
|                       | distribution within   |                      |
|                       | the European          |                      |
|                       | Union.***             |                      |
+-----------------------+-----------------------+----------------------+
| Article 82.1          | Amendment 133         | See amendment 142    |
|                       |                       | (Article 87).        |
| 1\. The Agency shall  | 1\. The Agency shall  |                      |
| be managed by its     | be managed by its     |                      |
| Executive Director,   | Executive Director.   |                      |
| ***who shall perform  |                       |                      |
| his duties in the     |                       |                      |
| interests of the      |                       |                      |
| Community, and        |                       |                      |
| independently of any  |                       |                      |
| specific              |                       |                      |
| interests.***         |                       |                      |
+-----------------------+-----------------------+----------------------+
| Article 82.2 (ja)     | Amendment134          | It was agreed to     |
|                       |                       | introduce the        |
| Does not exist.       | ***(ja) establishing  | following            |
|                       | and maintaining       | subparagraph (ja) in |
|                       | contact with the      | order to ensure      |
|                       | European Parliament   | appropriate          |
|                       | and ensuring that a   | reporting and a flow |
|                       | regular dialogue is   | of information from  |
|                       | held with that        | the European         |
|                       | institutions's        | Chemicals Agency to  |
|                       | relevant              | the EP:              |
|                       | committee;***         |                      |
|                       |                       | [                    |
|                       |                       | (]{.underline}***ja) |
|                       |                       | establishing and     |
|                       |                       | maintaining regular  |
|                       |                       | dialogue with the    |
|                       |                       | European             |
|                       |                       | Parliament.***       |
+-----------------------+-----------------------+----------------------+
|                       |                       | It was agreed to     |
|                       |                       | ensure consistency,  |
|                       |                       | that a new point     |
|                       |                       | (ka) be added to     |
|                       |                       | Article 82.2 as      |
|                       |                       | follows:             |
|                       |                       |                      |
|                       |                       | ***(ka) rectifying a |
|                       |                       | decision made by the |
|                       |                       | Agency on appeal and |
|                       |                       | after consulting     |
|                       |                       | with the chairman of |
|                       |                       | the Board of Appeal. |
|                       |                       | ^(#)^***             |
|                       |                       |                      |
|                       |                       | ***[^(#)^ Commission |
|                       |                       | technical point Nr   |
|                       |                       | 31]{.underline}***   |
+-----------------------+-----------------------+----------------------+
| Article 82.3.a        | Amendment 135         | It was agreed to     |
|                       |                       | redraft Article 82   |
| Does not exist.       | ***3a. Once the       | in the following way |
|                       | general report and    | to ensure            |
|                       | the programmes have   | appropriate          |
|                       | been approved by the  | reporting and a flow |
|                       | Management Board, the | of information from  |
|                       | Executive Director    | the European         |
|                       | shall forward them to | Chemicals Agency to  |
|                       | the European          | the EP:              |
|                       | Parliament, the       |                      |
|                       | Council, the          | *Article 82*         |
|                       | Commission and the    |                      |
|                       | Member States, and    | *Duties and powers   |
|                       | shall arrange for     | of the Executive     |
|                       | them to be            | Director*            |
|                       | published.***         |                      |
|                       |                       | 1\. The Agency shall |
|                       |                       | be managed by its    |
|                       |                       | Executive Director,  |
|                       |                       | who shall perform    |
|                       |                       | his duties in the    |
|                       |                       | interest of the      |
|                       |                       | Community, and       |
|                       |                       | independently of any |
|                       |                       | specfic interests.   |
|                       |                       |                      |
|                       |                       | 2\. ...              |
|                       |                       |                      |
|                       |                       | 3\. Each year the    |
|                       |                       | Executive Director   |
|                       |                       | shall submit the     |
|                       |                       | following to the     |
|                       |                       | Management Board for |
|                       |                       | approval:            |
|                       |                       |                      |
|                       |                       | > (a)...             |
|                       |                       | >                    |
|                       |                       | > (b)...             |
|                       |                       | >                    |
|                       |                       | > (c)...             |
|                       |                       | >                    |
|                       |                       | > (d)...             |
|                       |                       | >                    |
|                       |                       | > (e)...             |
|                       |                       |                      |
|                       |                       | ***The Executive     |
|                       |                       | Director shall,      |
|                       |                       | following adoption   |
|                       |                       | by the Management    |
|                       |                       | Board, forward the   |
|                       |                       | work programme for   |
|                       |                       | the coming year and  |
|                       |                       | the multi-annual     |
|                       |                       | work programme to    |
|                       |                       | the Member States,   |
|                       |                       | the European         |
|                       |                       | Parliament, the      |
|                       |                       | Council, and the     |
|                       |                       | Commission, and      |
|                       |                       | shall have them      |
|                       |                       | published.***        |
|                       |                       |                      |
|                       |                       | ***The Executive     |
|                       |                       | Director shall,      |
|                       |                       | following adoption   |
|                       |                       | by the Management    |
|                       |                       | Board, forward the   |
|                       |                       | Agency's general     |
|                       |                       | report to the Member |
|                       |                       | States, the European |
|                       |                       | Parliament, the      |
|                       |                       | Council, the         |
|                       |                       | Commission, the      |
|                       |                       | European Economic    |
|                       |                       | and Social           |
|                       |                       | Committee, and the   |
|                       |                       | Court of Auditors,   |
|                       |                       | and shall have it    |
|                       |                       | published.***        |
|                       |                       |                      |
|                       |                       | In addition,         |
|                       |                       | consequential        |
|                       |                       | changes must be made |
|                       |                       | in Article 77        |
|                       |                       | (Powers of the       |
|                       |                       | Management Board).   |
|                       |                       |                      |
|                       |                       | *Article 77\         |
|                       |                       | Powers of the        |
|                       |                       | Management Board*    |
|                       |                       |                      |
|                       |                       | The Management Board |
|                       |                       | shall appoint the    |
|                       |                       | Executive Director   |
|                       |                       | pursuant to          |
|                       |                       | Article 83 and an    |
|                       |                       | accounting officer   |
|                       |                       | in accordance with   |
|                       |                       | Article 43 of        |
|                       |                       | Regulation (EC,      |
|                       |                       | Euratom)             |
|                       |                       | No 2343/2002.        |
|                       |                       |                      |
|                       |                       | It shall adopt:      |
|                       |                       |                      |
|                       |                       | \(a\) by 30 April    |
|                       |                       | each year, the       |
|                       |                       | general report of    |
|                       |                       | the Agency for the   |
|                       |                       | previous year ~~and  |
|                       |                       | forward it by 15     |
|                       |                       | June at the latest   |
|                       |                       | to the Member        |
|                       |                       | States, the European |
|                       |                       | Parliament, the      |
|                       |                       | Council, the         |
|                       |                       | Commission, the      |
|                       |                       | European Economic    |
|                       |                       | and Social Committee |
|                       |                       | and the Court of     |
|                       |                       | Auditors~~;          |
|                       |                       |                      |
|                       |                       | \(b\) by 31 October  |
|                       |                       | each year the work   |
|                       |                       | programme of the     |
|                       |                       | Agency for the       |
|                       |                       | coming year ~~and    |
|                       |                       | forward it to the    |
|                       |                       | Member States, the   |
|                       |                       | European Parliament, |
|                       |                       | the Council and the  |
|                       |                       | Commission~~;        |
|                       |                       |                      |
|                       |                       | \(c\) .....          |
+-----------------------+-----------------------+----------------------+
| Article 83.1          | Amendment 136         | It was agreed to     |
|                       |                       | incorporate this     |
| ***1. The Commission  | ***deleted***         | paragraph (Article   |
| shall propose         |                       | 83.1) into Article   |
| candidates for the    |                       | 83.2 in a redrafted  |
| post of the Executive |                       | format (See          |
| Director based on a   |                       | Amendment 137        |
| list following        |                       | below).              |
| publication of the    |                       |                      |
| post in the Official  |                       |                      |
| Journal of the        |                       |                      |
| European Union and    |                       |                      |
| other press or        |                       |                      |
| internet sites as     |                       |                      |
| appropriate.***       |                       |                      |
+-----------------------+-----------------------+----------------------+
| Article 83.2 subpara  | Amendment 137         | It was agreed that   |
| 1                     |                       | the Executive        |
|                       | 2\. The Executive     | Director would be    |
| 2\. The Executive     | Director of the       | invited to introduce |
| Director of the       | Agency shall be       | himself/herself to   |
| Agency shall be       | appointed by the      | the EP as soon as    |
| appointed by the      | Management Board      | possible before      |
| Management Board      | ***from among a list  | his/her appointment. |
|                       | of candidates         | This would initiate  |
| on the grounds of     | proposed by the       | and facilitate the   |
| merit and documented  | Commission following  | regular dialogue     |
| administrative and    | a public-selection    | between the          |
| management skills, as | procedure advertised  | Executive Director   |
| well as his relevant  | by means of a call    | and the EP.          |
| experience in the     | for expressions of    |                      |
| fields of chemical    | interest published in | *Article 83*         |
| safety or regulation. | the Official Journal  |                      |
| The Management Board  | of the European Union | *Appointment of the  |
| shall take its        | and in other          | Executive Director*  |
| decision by a         | periodicals or on     |                      |
| two-thirds majority   | Internet sites. Prior | 1 ***Delete.***      |
| of all members with a | to nomination the     |                      |
| right to vote.        | candidate designated  | 2\. The Executive    |
|                       | by the Management     | Director of the      |
|                       | Board shall be asked  | Agency shall be      |
|                       | as soon as possible   | appointed by the     |
|                       | to make a statement   | Management Board,    |
|                       | before the European   | ***on the basis of   |
|                       | Parliament and to     | list of candidates   |
|                       | answer questions from | proposed by the      |
|                       | Parliament's          | Commission following |
|                       | Members.***           | a call for           |
|                       |                       | expressions of       |
|                       | ***The Executive      | interest published   |
|                       | Director shall be     | in the Official      |
|                       | nominated*** on the   | Journal of European  |
|                       | grounds of merit and  | Communities and in   |
|                       | documented            | other periodicals or |
|                       | administrative and    | on Internet          |
|                       | management skills, as | sites.***            |
|                       | well as his relevant  |                      |
|                       | experience in the     | ***The Executive     |
|                       | fields of chemical    | Director shall be    |
|                       | safety or regulation. | appointed*** on the  |
|                       | The Management Board  | grounds of merit and |
|                       | shall take its        | documented           |
|                       | decision by a         | administrative and   |
|                       | two-thirds majority   | management skills,   |
|                       | of all members with a | as well as his       |
|                       | right to vote.        | relevant experience  |
|                       |                       | in the fields of     |
|                       |                       | chemical safety or   |
|                       |                       | regulation. The      |
|                       |                       | Management Board     |
|                       |                       | shall take its       |
|                       |                       | decision by a        |
|                       |                       | two-thirds majority  |
|                       |                       | of all members with  |
|                       |                       | a right to vote.     |
|                       |                       |                      |
|                       |                       | ***Before being      |
|                       |                       | appointed, the       |
|                       |                       | candidate selected   |
|                       |                       | by the Management    |
|                       |                       | Board shall be       |
|                       |                       | invited as soon as   |
|                       |                       | possible to make a   |
|                       |                       | statement before the |
|                       |                       | European Parliament  |
|                       |                       | and to answer        |
|                       |                       | questions from       |
|                       |                       | Parliament's         |
|                       |                       | Members.***          |
+-----------------------+-----------------------+----------------------+
| Article 85.1-3        | Amendment 139         | It was agreed that   |
|                       |                       | members of the       |
| 1\. Each Member State | 1\. Each Member State | Management Board     |
| shall appoint, for a  | shall appoint, for a  | should not           |
| three-year term,      | three-year term,      | simultaneously be    |
| which shall be        | which shall be        | members of the       |
| renewable, one member | renewable, one member | Forum.               |
| to the Forum. Members | to the Forum. Members |                      |
| shall be chosen for   | shall be chosen for   | 1\. Each Member      |
| their role and        | their role and        | State shall appoint, |
| experience in         | experience in         | for a three-year     |
| enforcement of        | enforcement of        | term, which shall be |
| chemicals legislation | chemicals legislation | renewable, one       |
| and shall maintain    | and shall maintain    | member to the Forum. |
| relevant contacts     | relevant contacts     | Members shall be     |
| with the Member State | with the Member State | chosen for their     |
| competent             | competent             | role and experience  |
| authorities.          | authorities.          | in enforcement of    |
|                       |                       | chemicals            |
| The Forum should aim  | The Forum shall aim   | legislation and      |
| to have a broad range | to have a broad range | shall maintain       |
| of relevant expertise | of relevant expertise | relevant contacts    |
| among its members. To | among its members. To | with the Member      |
| this end the Forum    | this end the Forum    | State competent      |
| may co-opt a maximum  | may coopt a maximum   | authorities.         |
| of five additional    | of five additional    |                      |
| members chosen on the | members chosen on the | The Forum should aim |
| basis of their        | basis of their        | to have a broad      |
| specific competence.  | specific competence.  | range of relevant    |
| These members shall   | These members shall   | expertise among its  |
| be appointed for a    | be appointed for a    | members. To this end |
| term of three years,  | term of three years,  | the Forum may co-opt |
| which shall be        | which shall be        | a maximum of five    |
| renewable.            | renewable.            | additional members   |
|                       |                       | chosen on the basis  |
| The members of the    | The members of the    | of their specific    |
| Forum may be          | Forum may be          | competence. These    |
| accompanied by        | accompanied by        | members shall be     |
| scientific and        | scientific and        | appointed for a term |
| technical advisers.   | technical advisers.   | of three years,      |
|                       |                       | which shall be       |
| The Executive         | The Executive         | renewable.           |
| Director of the       | Director of the       | ***Members of the    |
| Agency or his         | Agency or his         | Management Board may |
| representative and    | representative and    | not be members of    |
| representatives of    | representatives of    | the Forum***.        |
| the Commission shall  | the Commission shall  |                      |
| be entitled to attend | be entitled to attend | The members of the   |
| all the meetings of   | all the meetings of   | Forum may be         |
| the Forum and its     | the Forum and its     | accompanied by       |
| working groups.       | working groups.       | scientific and       |
| Stakeholders may also | Stakeholders may also | technical advisers.  |
| ***be invited to***   | attend meetings as    |                      |
| attend meetings as    | observers.            | The Executive        |
| observers, ***as      |                       | Director of the      |
| appropriate, at the   | ***Members of the     | Agency or his        |
| request of Forum      | Forum may not be      | representative and   |
| members, or the       | members of the        | representatives of   |
| Management Board**.*  | Management Board.***  | the Commission shall |
|                       |                       | be entitled to       |
| 2\. The members of    | 2\. The members of    | attend all the       |
| the Forum appointed   | the Forum appointed   | meetings of the      |
| by a Member State     | by a Member State     | Forum and its        |
| shall ensure that     | shall ensure that     | working groups.      |
| there is appropriate  | there is appropriate  | Stakeholders may     |
| co-ordination between | coordination between  | also be invited to   |
| the tasks of the      | the tasks of the      | attend meetings as   |
| Forum and the work of | Forum and the work of | observers, as        |
| their Member State    | their Member State    | appropriate, at the  |
| competent authority.  | competent authority.  | request of Forum     |
|                       |                       | members, or the      |
| 3\. The members of    | 3\. The members of    | Management Board.    |
| the Forum shall be    | the Forum shall be    |                      |
| supported by the      | supported by the      | 2\. The members of   |
| scientific and        | scientific and        | the Forum appointed  |
| technical resources   | technical resources   | by a Member State    |
| available to the      | available to the      | shall ensure that    |
| competent authorities | competent authorities | there is appropriate |
| of the Member States. | of the Member States. | co-ordination        |
| Each Member State     | Each Member State     | between the tasks of |
| competent authority   | competent authority   | the Forum and the    |
| shall facilitate the  | shall facilitate the  | work of their Member |
| activities of the     | activities of the     | State competent      |
| Forum and its working | Forum and its working | authority.           |
| groups. ***The Member | groups.               |                      |
| States shall refrain  |                       | 3\. The members of   |
| from giving the Forum |                       | the Forum shall be   |
| members, or their     |                       | supported by the     |
| scientific and        |                       | scientific and       |
| technical advisers    |                       | technical resources  |
| and experts any       |                       | available to the     |
| instruction which is  |                       | competent            |
| incompatible with the |                       | authorities of the   |
| individual tasks of   |                       | Member States. Each  |
| those persons or with |                       | Member State         |
| the tasks and         |                       | competent authority  |
| responsibilities of   |                       | shall facilitate the |
| the Forum.***         |                       | activities of the    |
|                       |                       | Forum and its        |
|                       |                       | working groups. The  |
|                       |                       | Member States shall  |
|                       |                       | refrain from giving  |
|                       |                       | the Forum members,   |
|                       |                       | or their scientific  |
|                       |                       | and technical        |
|                       |                       | advisers and experts |
|                       |                       | any instruction      |
|                       |                       | which is             |
|                       |                       | incompatible with    |
|                       |                       | the individual tasks |
|                       |                       | of those persons or  |
|                       |                       | with the tasks and   |
|                       |                       | responsibilities of  |
|                       |                       | the Forum.           |
+-----------------------+-----------------------+----------------------+
| Article 86.1          | Amendment 140         | It was agreed to     |
|                       |                       | delete \"take a      |
| 1\. Where, in         | 1\. Where, in         | decision\" and       |
| accordance with       | accordance with       | retain the rest of   |
| Article 76, a         | Article 76, a         | the text of the      |
| Committee is required | Committee is required | Common Position.     |
| to ***take a          | to provide an opinion |                      |
| decision***, provide  | or consider whether a | 1\. Where, in        |
| an opinion or         | Member State dossier  | accordance with      |
| consider whether a    | conforms with the     | Article 76, a        |
| Member State dossier  | requirements of Annex | Committee is         |
| conforms with the     | XV, it shall appoint  | required to ~~take a |
| requirements of Annex | one of its members as | decision~~, provide  |
| XV, it shall appoint  | a rapporteur. The     | an opinion or        |
| one of its members as | Committee concerned   | consider whether a   |
| a rapporteur. The     | may appoint a second  | Member State dossier |
| Committee concerned   | member to act as      | conforms with the    |
| may appoint a second  | co-rapporteur. A      | requirements of      |
| member to act as      | member of a Committee | Annex XV, it shall   |
| co-rapporteur. ***For | shall not be          | appoint one of its   |
| each case,            | appointed rapporteur  | members as a         |
| rapporteurs and       | for a particular case | rapporteur. The      |
| co‑rapporteurs shall  | if he indicates any   | Committee concerned  |
| undertake to act in   | interest that might   | may appoint a second |
| the interests of the  | be prejudicial to the | member to act as     |
| Community and shall   | independent           | co-rapporteur. For   |
| make a declaration of | consideration of that | each case,           |
| commitment to fulfil  | case. The Committee   | rapporteurs and      |
| their duties and a    | concerned may replace | co‑rapporteurs shall |
| declaration of        | the rapporteur or     | undertake to act in  |
| interests in          | co-rapporteur by      | the interests of the |
| writing.*** A member  | another one of its    | Community and shall  |
| of a Committee shall  | members at any time,  | make a declaration   |
| not be appointed      | if, for example, they | of commitment to     |
| rapporteur for a      | are unable to fulfil  | fulfil their duties  |
| particular case if he | their duties within   | and a declaration of |
| indicates any         | the prescribed time   | interests in         |
| interest that might   | limits, or if a       | writing. A member of |
| be prejudicial to the | potentially           | a Committee shall    |
| independent           | prejudicial interest  | not be appointed     |
| consideration of that | comes to light.       | rapporteur for a     |
| case. The Committee   |                       | particular case if   |
| concerned may replace |                       | he indicates any     |
| the rapporteur or     |                       | interest that might  |
| co-rapporteur by      |                       | be prejudicial to    |
| another one of its    |                       | the independent      |
| members at any time,  |                       | consideration of     |
| if, for example, they |                       | that case. The       |
| are unable to fulfil  |                       | Committee concerned  |
| their duties within   |                       | may replace the      |
| the prescribed time   |                       | rapporteur or        |
| limits, or if a       |                       | co-rapporteur by     |
| potentially           |                       | another one of its   |
| prejudicial interest  |                       | members at any time, |
| comes to light.       |                       | if, for example,     |
|                       |                       | they are unable to   |
|                       |                       | fulfil their duties  |
|                       |                       | within the           |
|                       |                       | prescribed time      |
|                       |                       | limits, or if a      |
|                       |                       | potentially          |
|                       |                       | prejudicial interest |
|                       |                       | comes to light.      |
+-----------------------+-----------------------+----------------------+

+-----------------------+-----------------------+----------------------+
| Article 87            | Amendment 142         | It was agreed to     |
|                       |                       | make the annual      |
| *Article 87*          | *Article 87*          | declarations of      |
|                       |                       | interest public, in  |
| ***Qualifications and | ***Independence***    | order to increase    |
| interests***          |                       | openness and         |
|                       | 1\. The membership of | transparency. The    |
| 1\. The membership of | the Committees and of | text would read as   |
| the Committees and of | the Forum shall be    | follows:             |
| the Forum shall be    | made public. When     |                      |
| made public.          | each appointment is   | *Article 87*         |
| ***Individual members | published, the        |                      |
| may request that      | professional          | *Qualification and   |
| their names not be    | qualifications of     | interests*           |
| made public if they   | each member shall be  |                      |
| believe that such     | specified.            | 1\. The membership   |
| publication could     |                       | of the Committees    |
| place them at risk.   | 2\. Members of the    | and of the Forum     |
| The Executive         | Management Board, the | shall be made        |
| Director shall decide | Executive             | public. Individual   |
| whether to agree to   | Director***,***       | members may request  |
| such requests.***     | members of the        | that their names not |
| When each appointment | Committees***,        | be made public if    |
| is published, the     | members*** of the     | they believe that    |
| professional          | Forum***, members of  | such publication     |
| qualifications of     | the Board of Appeal,  | could place them at  |
| each member shall be  | experts and           | risk. The Executive  |
| specified.            | scientific and        | Director shall       |
|                       | technical advisers    | decide whether to    |
| 2\. Members of the    | shall not have        | agree to such        |
| Management Board, the | economic or other     | requests. When each  |
| Executive Director    | interests in the      | appointment is       |
| ***and*** members of  | chemical sector which | published, the       |
| the Committees        | may prejudice their   | professional         |
| ***and*** of the      | impartiality. They    | qualifications of    |
| Forum shall make a    | shall undertake to    | each member shall be |
| declaration of        | act independently and | specified.           |
| commitment to fulfil  | in the public         |                      |
| their duties and a    | interest and*** shall | 2\. Members of the   |
| declaration of        | ***each year*** make  | Management Board,    |
| interests ***which    | a declaration of      | the Executive        |
| could be considered   | ***their financial*** | Director and members |
| to be prejudicial to  | interests***. Any     | of the Committees    |
| their independence.   | indirect interests    | and of the Forum     |
| These declarations    | relating to the       | shall make a         |
| shall be made         | chemical industry     | declaration of       |
| annually in           | shall be declared in  | commitment to        |
| writing.***           | a register held by    | fulfill their duties |
|                       | the Agency and        | and a declaration of |
| 3\. At each of their  | accessible to the     | interests which      |
| meetings, members of  | public on request at  | could be considered  |
| the Management Board, | the Agency's          | to be prejudicial to |
| the Executive         | offices***.           | their independence.  |
| Director, members of  |                       | These declarations   |
| the Committees        | ***Member States      | shall be made        |
| ***and*** of the      | shall refrain from    | annually in writing  |
| Forum and any experts | giving the members of | ***and, without      |
| participating in the  | the Risk Assessment   | prejudice to         |
| meeting shall declare | Committee, of the     | paragraph 1, shall   |
| any interests which   | Socio-Economic        | be entered in a      |
| could be considered   | Analysis Committee,   | register held by the |
| to be prejudicial to  | of the Forum or of    | Agency which is      |
| their independence    | the Board of Appeal,  | accessible to the    |
| with respect to any   | or their scientific   | public, on request,  |
| points on the agenda. | and technical         | at the Agency\'s     |
| Anyone declaring such | advisers and experts, | offices.***          |
| interests shall       | any instruction which |                      |
| ***not*** participate | is incompatible with  | 3\. At each of their |
| in any voting ***on   | the individual tasks  | meetings, members of |
| the relevant agenda   | of those persons or   | the Management       |
| point.***             | with the tasks,       | Board, the Executive |
|                       | responsibilities and  | Director, members of |
|                       | independence of the   | the Committees and   |
|                       | Agency.***            | of the Forum and any |
|                       |                       | experts              |
|                       | ***The Agency's code  | participating in the |
|                       | of practice shall     | meeting shall        |
|                       | specify measures      | declare any          |
|                       | relating to the       | interests which      |
|                       | application of this   | could be considered  |
|                       | article.***           | to be prejudicial to |
|                       |                       | their independence   |
|                       | 3\. At each of their  | with respect to any  |
|                       | meetings, members of  | points on the        |
|                       | the Management Board, | agenda. Anyone       |
|                       | the Executive         | declaring such       |
|                       | Director, members of  | interests shall not  |
|                       | the Committees***,    | participate in any   |
|                       | members*** of the     | voting on the        |
|                       | Forum and any experts | relevant agenda      |
|                       | ***and scientific and | point.               |
|                       | technical advisers*** |                      |
|                       | participating in the  | [Consequential       |
|                       | meeting shall declare | Change in Article    |
|                       | any interests which   | 84.1 and             |
|                       | could be considered   | 84.2]{.underline}:   |
|                       | to be prejudicial to  |                      |
|                       | their independence    | 1\. Each Member      |
|                       | with respect to any   | State may nominate   |
|                       | points on the agenda. | candidates to        |
|                       | Anyone declaring such | membership of the    |
|                       | interests shall       | Committee for Risk   |
|                       | ***participate        | Assessment. The      |
|                       | neither*** ***in the  | Executive Director   |
|                       | discussion of the     | shall establish a    |
|                       | relevant agenda       | list of the          |
|                       | points nor*** in any  | nominees, which      |
|                       | voting                | shall be published   |
|                       | ***thereupon***.      | on the Agency\'s     |
|                       | ***Such declarations  | website, ***without  |
|                       | shall be made         | prejudice to Article |
|                       | publicly              | 87.1***. The         |
|                       | accessible.***        | Management Board     |
|                       |                       | shall appoint the    |
|                       |                       | members of the       |
|                       |                       | Committee from this  |
|                       |                       | list, including at   |
|                       |                       | least one member but |
|                       |                       | not more than two    |
|                       |                       | from the nominees of |
|                       |                       | each Member State    |
|                       |                       | that has nominated   |
|                       |                       | candidates. Members  |
|                       |                       | shall be appointed   |
|                       |                       | for their role and   |
|                       |                       | experience in        |
|                       |                       | performing the tasks |
|                       |                       | specified in Article |
|                       |                       | 76(3).               |
|                       |                       |                      |
|                       |                       | 2\. Each Member      |
|                       |                       | State may nominate   |
|                       |                       | candidates to        |
|                       |                       | membership of the    |
|                       |                       | Committee for        |
|                       |                       | Socio‑economic       |
|                       |                       | Analysis. The        |
|                       |                       | Executive Director   |
|                       |                       | shall establish a    |
|                       |                       | list of the          |
|                       |                       | nominees, which      |
|                       |                       | shall be published   |
|                       |                       | on the Agency\'s     |
|                       |                       | website, ***without  |
|                       |                       | prejudice to Article |
|                       |                       | 87.1***. The         |
|                       |                       | Management Board     |
|                       |                       | shall appoint the    |
|                       |                       | members of the       |
|                       |                       | Committee from this  |
|                       |                       | list, including at   |
|                       |                       | least one member but |
|                       |                       | not more than two    |
|                       |                       | from the nominees of |
|                       |                       | each Member State    |
|                       |                       | that has nominated   |
|                       |                       | candidates. Members  |
|                       |                       | shall be appointed   |
|                       |                       | for their role and   |
|                       |                       | experience in        |
|                       |                       | performing the tasks |
|                       |                       | specified in         |
|                       |                       | Article 76(3).       |
+-----------------------+-----------------------+----------------------+
| Article 88.3 subpara  | Amendment 143         | It was agreed to     |
| 1                     |                       | introduce a          |
|                       | 3\. The Chairman, the | public-selection     |
| 3\. The Chairman, the | other members and the | procedure. The text  |
| other members and the | alternates shall be   | reads as follows:    |
| alternates shall be   | appointed by the      |                      |
| appointed by the      | Management Board      | 3\. The Chairman,    |
| Management Board on   | ***from among a list  | the other members    |
| the basis of their    | of qualified          | and the alternates   |
| relevant experience   | candidates proposed   | shall be appointed   |
| and expertise in the  | by the Commission     | by the Management    |
| field of chemical     | following a           | Board ***on the      |
| safety, natural       | public-selection      | basis of a list of   |
| sciences or           | procedure advertised  | candidates proposed  |
| regulatory and        | by means of a call    | by the Commission    |
| judicial procedures   | for expressions of    | following a call for |
| ***from a list of     | interest published in | expressions of       |
| qualified candidates  | the Official Journal  | interest published   |
| adopted by the        | of the European Union | in the Official      |
| Commission***.        | and in other          | Journal of European  |
|                       | periodicals or on     | Communities and in   |
|                       | Internet sites. The   | other periodicals or |
|                       | members of the Board  | on Internet sites.   |
|                       | of Appeal shall be    | They shall be        |
|                       | selected*** on the    | appointed*** on the  |
|                       | basis of their        | basis of their       |
|                       | relevant experience   | relevant             |
|                       | and expertise in the  | experience...        |
|                       | field of chemical     |                      |
|                       | safety, natural       |                      |
|                       | sciences or           |                      |
|                       | regulatory and        |                      |
|                       | judicial procedures.  |                      |
+-----------------------+-----------------------+----------------------+
| Article 89.2 and 3    | Amendment 145         | It was agreed to     |
|                       |                       | delete the           |
| ***2. The Members of  | **deleted**           | possibility of       |
| the Board of Appeal   |                       | part-time function   |
| shall be independent. | 3\. The members of    | of the members of    |
| In making their       | the Board of Appeal   | the Board of Appeal. |
| decisions they shall  | may not perform any   | Otherwise the text   |
| not be bound by any   | other duties in the   | of the Common        |
| instructions.***      | Agency.               | Position will be     |
|                       |                       | retained. The text   |
| 3\. The members of    |                       | reads as follows:    |
| the Board of Appeal   |                       |                      |
| may not perform any   |                       | 2\. The Members of   |
| other duties in the   |                       | the Board of Appeal  |
| Agency. ***The        |                       | shall be             |
| function of the       |                       | independent. In      |
| Members may be a      |                       | making their         |
| part-time             |                       | decisions they shall |
| function.***          |                       | not be bound by any  |
|                       |                       | instructions.        |
|                       |                       |                      |
|                       |                       | 3\. The members of   |
|                       |                       | the Board of Appeal  |
|                       |                       | may not perform any  |
|                       |                       | other duties in the  |
|                       |                       | Agency. ~~The        |
|                       |                       | function of the      |
|                       |                       | Members may be a     |
|                       |                       | part-time            |
|                       |                       | function.~~          |
+-----------------------+-----------------------+----------------------+

+-----------------------+-----------------------+----------------------+
| Article 133           | Amendment 158         | It was agreed to     |
|                       |                       | redraft Article 133  |
| *Artcle 133*          | *Artcle 133*          | as follows:          |
|                       |                       |                      |
| ***Transitional       | ***Preparation of     | *Article 133*        |
| measures regarding    | establishment of the  |                      |
| the Agency***         | Agency***             | ***Preparation of    |
|                       |                       | establishment of the |
| 1\. The Commission    | 1\. The Commission    | Agency***            |
| shall ***provide***   | shall ***afford***    |                      |
| the necessary support | the necessary support | 1\. The Commission   |
| towards ***the        | ***towards*** ***the  | shall ***afford***   |
| setting up*** of the  | establishment*** of   | the necessary        |
| Agency.               | the Agency.           | support ***towards** |
|                       |                       | **the                |
| 2\. For that purpose, | 2\. For that purpose, | establishment*** of  |
| until such time as    | until such time as    | the Agency.          |
| the Executive         | the Executive         |                      |
| Director ***is        | Director ***assumes   | 2\. For that         |
| appointed*** in       | his duties following  | purpose, until such  |
| accordance with       | his appointment by    | time as the          |
| Article 83, the       | the Management        | Executive Director   |
| Commission, on behalf | Board*** in           | ***assumes his       |
| of the Agency,        | accordance with       | duties following his |
| ***thereby*** using   | Article 83, the       | appointment by the   |
| the budget provided   | Commission, on behalf | Management Board of  |
| for the latter, may   | of the Agency,        | the Agency*** in     |
|                       | ***and*** using the   | accordance with      |
| appoint personnel,    | budget provided for   | Article 83, the      |
| including a person    | the latter, may:      | Commission, on       |
| who shall fulfil the  |                       | behalf of the        |
| ***administrative***  | ***(a)*** appoint     | Agency, ***and***    |
| functions of the      | personnel, including  | using the budget     |
| Executive Director on | a person who shall    | provided for the     |
| an interim basis, and | fulfil the functions  | latter, may:         |
|                       | of the Executive      |                      |
| conclude other        | Director on an        | **(a)** appoint      |
| contracts.            | interim basis; and    | personnel, including |
|                       |                       | a person who shall   |
|                       | ***(b)*** conclude    | fulfil the           |
|                       | other contracts.      | administrative       |
|                       |                       | functions of the     |
|                       |                       | Executive Director   |
|                       |                       | on an interim basis; |
|                       |                       | and                  |
|                       |                       |                      |
|                       |                       | **(b)** conclude     |
|                       |                       | other contracts.     |
+-----------------------+-----------------------+----------------------+

**6. REGISTRATION/DATA SHARING**

+-----------------------+-----------------------+----------------------+
| **Council Common      | **EP amendment**      | **Result of the 6th  |
| Position**            |                       | trilogue**           |
+-----------------------+-----------------------+----------------------+
| Recital 51 a          | Amendment 14          | It was agreed to     |
|                       |                       | respond to Amendment |
| Does not exist.       | ***(51a) If a         | 14 by modifying      |
|                       | manufacturer of a     | Recital 50 taking    |
|                       | substance or an       | into account the     |
|                       | importer of a         | modification of      |
|                       | substance, either on  | Article 28 as        |
|                       | its own or in a       | response to          |
|                       | preparation, does not | Amendment 55 (see    |
|                       | intend to submit a    | below).              |
|                       | registration for a    |                      |
|                       | substance, he must    |                      |
|                       | notify the Agency and |                      |
|                       | his downstream users  |                      |
|                       | accordingly.***       |                      |
+-----------------------+-----------------------+----------------------+
| Article 3.29          | Amendment 35          | It was agreed to     |
|                       |                       | follow the ideas     |
| 29\. Per year means   | 29\) Per year: means  | behind this          |
| per calendar year     | per calendar year.    | Amendment but that   |
| unless stated         | ***Save in the case   | the text should be   |
| otherwise.            | of new substances,    | modified as follows: |
|                       | and*** unless stated  |                      |
|                       | otherwise***,***      | *Article 3*          |
|                       | ***quantities per     |                      |
|                       | year shall be         | 29\) Per year: means |
|                       | calculated on the     | per calendar year.   |
|                       | basis of the average  | Unless stated        |
|                       | production volumes    | otherwise***, for    |
|                       | for the three         | phase-in substances  |
|                       | immediately preceding | that have been       |
|                       | calendar years during | imported or          |
|                       | which the substance   | manufactured for at  |
|                       | has actually been     | least three          |
|                       | produced by the       | consecutive years,   |
|                       | manufacturer;***      | quantities per year  |
|                       |                       | shall be calculated  |
|                       |                       | on the basis of the  |
|                       |                       | average production   |
|                       |                       | or import volumes    |
|                       |                       | for the three        |
|                       |                       | preceding calendar   |
|                       |                       | years;***            |
+-----------------------+-----------------------+----------------------+
| Article 3 points 35   | Amendment 121 (ENVI)  | It was agreed to     |
| and 36                |                       | introduce the        |
|                       | ARTICLE 3, POINT 35   | following changes to |
| 35\) Exposure         |                       | the text:            |
| scenario: means the   | 35\. Exposure         |                      |
| set of conditions     | scenario means the    | 35\. Exposure        |
| that describe how the | set of conditions     | scenario: means the  |
| substance is          | ***including risk     | set of conditions,   |
| manufactured or used  | management            | ***including         |
| during its life-cycle | measures*** that      | operational          |
| and how the           | describe how the      | conditions and risk  |
| manufacturer or       | substance is          | management           |
| importer controls, or | manufactured or used  | measures***, that    |
| recommends downstream | during its life-cycle | describe how the     |
| users to control,     | and how the           | substance is         |
| exposures of humans   | manufacturer          | manufactured or used |
| and the environment.  | ***and*** importer    | during its           |
| These exposure        |                       | life-cycle and how   |
| scenarios may cover   | controls, or          | the manufacturer or  |
| one specific process  | recommends ***to***   | importer controls,   |
| or use or several     | downstream users      | or recommends        |
| processes or uses as  | ***that they may***   | downstream users to  |
| appropriate;          | control exposures of  | control, exposures   |
|                       | humans and the        | of humans and the    |
| 36\) Use and exposure | environment. These    | environment. These   |
| category: means an    | exposure scenarios    | exposure scenarios   |
| exposure scenario     | may cover one         | may cover one        |
| covering a wide range | specific              | specific process or  |
| of processes or uses; |                       | use or several       |
|                       | process or use or     | processes or uses as |
|                       | several processes or  | appropriate;         |
|                       | uses, as appropriate, |                      |
|                       | ***where these        | 36\. Use and         |
|                       | processes or uses may | exposure category:   |
|                       | be described in terms | means an exposure    |
|                       | of use and exposure   | scenario covering a  |
|                       | categories, as        | wide range of        |
|                       | defined.***           | processes or uses,   |
|                       |                       | ***where the         |
|                       | Amendment 122 (ENVI)  | processes or uses    |
|                       |                       | are communicated, as |
|                       | ARTICLE 3, POINT 36   | a minimum, in terms  |
|                       |                       | of the brief general |
|                       | 36\. Use and exposure | description of       |
|                       | category means        | use***;              |
|                       | ***themain use        |                      |
|                       | categories (e.g.      |                      |
|                       | industrial            |                      |
|                       | use,professional use, |                      |
|                       | consumer use) and     |                      |
|                       | thesignificant routes |                      |
|                       | of exposure (e.g.     |                      |
|                       | oral, dermal,         |                      |
|                       | inhalation,           |                      |
|                       | environmental) and*** |                      |
|                       |                       |                      |
|                       | ***patterns of        |                      |
|                       | exposure (e.g.        |                      |
|                       | frequent, accidental, |                      |
|                       | occasional,           |                      |
|                       | continuous).***       |                      |
+-----------------------+-----------------------+----------------------+
| Article 7.1 a         | Amendment 37          | It was agreed that   |
|                       |                       | the wording in the   |
| Does not exist.       | ***1a. Paragraph 1(a) | Common Position      |
|                       | shall not apply to    | should be retained.  |
|                       | substances which are  | The Commission       |
|                       | ingredients added to  | Statement in Annex C |
|                       | tobacco products      | responds to the      |
|                       | within the meaning of | concern and          |
|                       | Article 2(1) and (5)  | clarifies specific   |
|                       | of Directive          | effects of tobacco   |
|                       | 2001/37/EC of the     | additives will be    |
|                       | European Parliament   | addressed in the     |
|                       | and of the Council of | context of a         |
|                       | 5 June 2001 on the    | forthcoming review   |
|                       | approximation of the  | of the Tobacco       |
|                       | laws, regulations and | Products Directive.  |
|                       | administrative        |                      |
|                       | provisions of the     |                      |
|                       | Member States         |                      |
|                       | concerning the        |                      |
|                       | manufacture,          |                      |
|                       | presentation and sale |                      |
|                       | of tobacco            |                      |
|                       | products^1^.***       |                      |
|                       |                       |                      |
|                       | ***^1^ OJ L 194,      |                      |
|                       | 18.7.2001, p. 26.***  |                      |
+-----------------------+-----------------------+----------------------+
|                       |                       | [In order to         |
|                       |                       | guarantee            |
|                       |                       | consistency and      |
|                       |                       | workability, it was  |
|                       |                       | agreed to modify     |
|                       |                       | paragraph 1 of       |
|                       |                       | Article 23 as        |
|                       |                       | f                    |
|                       |                       | ollows:]{.underline} |
|                       |                       |                      |
|                       |                       | *Article 23*         |
|                       |                       |                      |
|                       |                       | *Specific provisions |
|                       |                       | for phase-in         |
|                       |                       | substances*          |
|                       |                       |                      |
|                       |                       | 1\. Article 5,       |
|                       |                       | Article 6, Article   |
|                       |                       | 7(1), ***Article 17, |
|                       |                       | Article              |
|                       |                       | 18^(#)\ ^***and      |
|                       |                       | Article 21 shall not |
|                       |                       | apply until ...\* to |
|                       |                       | the following        |
|                       |                       | substances :         |
|                       |                       |                      |
|                       |                       | \(a\) phase-in       |
|                       |                       | substances           |
|                       |                       | classified as        |
|                       |                       | carcinogenic,        |
|                       |                       | mutagenic or toxic   |
|                       |                       | to reproduction,     |
|                       |                       | category 1 or 2, in  |
|                       |                       | accordance with      |
|                       |                       | Directive 67/548/EEC |
|                       |                       | and manufactured in  |
|                       |                       | the Community or     |
|                       |                       | imported, in         |
|                       |                       | quantities reaching  |
|                       |                       | 1 tonne or more per  |
|                       |                       | year per             |
|                       |                       | manufacturer or per  |
|                       |                       | importer, at least   |
|                       |                       | once after ...\*\*;  |
|                       |                       |                      |
|                       |                       | \(b\) phase-in       |
|                       |                       | substances           |
|                       |                       | classified as very   |
|                       |                       | toxic to aquatic     |
|                       |                       | organisms which may  |
|                       |                       | cause long‑term      |
|                       |                       | adverse effects in   |
|                       |                       | the aquatic          |
|                       |                       | environment (R50/53) |
|                       |                       | in accordance with   |
|                       |                       | Directive            |
|                       |                       | 67/548/EEC, and      |
|                       |                       | manufactured in the  |
|                       |                       | Community or         |
|                       |                       | imported in          |
|                       |                       | quantities reaching  |
|                       |                       | 100 tonnes or more   |
|                       |                       | per year per         |
|                       |                       | manufacturer or per  |
|                       |                       | importer, at least   |
|                       |                       | once after \...\*;   |
|                       |                       |                      |
|                       |                       | \(c\) phase-in       |
|                       |                       | substances           |
|                       |                       | manufactured in the  |
|                       |                       | Community or         |
|                       |                       | imported, in         |
|                       |                       | quantities reaching  |
|                       |                       | 1 000 tonnes or more |
|                       |                       | per year per         |
|                       |                       | manufacturer or per  |
|                       |                       | importer, at least   |
|                       |                       | once after \*\*.     |
|                       |                       |                      |
|                       |                       | 2\. Article 5,       |
|                       |                       | Article 6, Article   |
|                       |                       | 7(1), ***Article 17, |
|                       |                       | Article 18^(#)^***   |
|                       |                       | and Article 21 shall |
|                       |                       | not apply until      |
|                       |                       | \*\*\* to phase-in   |
|                       |                       | substances           |
|                       |                       | manufactured in the  |
|                       |                       | Community or         |
|                       |                       | imported, in         |
|                       |                       | quantities reaching  |
|                       |                       | 100 tonnes or more   |
|                       |                       | per year per         |
|                       |                       | manufacturer or per  |
|                       |                       | importer, at least   |
|                       |                       | once after \*\*.     |
|                       |                       |                      |
|                       |                       | 3\. Article 5,       |
|                       |                       | Article 6, Article   |
|                       |                       | 7(1), ***Article 17, |
|                       |                       | Article 18^(#)^***   |
|                       |                       | and Article 21 shall |
|                       |                       | not apply until      |
|                       |                       | \*\*\*\* to phase-in |
|                       |                       | substances           |
|                       |                       | manufactured in the  |
|                       |                       | Community or         |
|                       |                       | imported, in         |
|                       |                       | quantities reaching  |
|                       |                       | 1 tonne or more per  |
|                       |                       | year per             |
|                       |                       | manufacturer or per  |
|                       |                       | importer, at least   |
|                       |                       | once after \*\*      |
|                       |                       |                      |
|                       |                       | \* ~~3 years~~       |
|                       |                       | ***[42               |
|                       |                       | mo                   |
|                       |                       | nths]{.underline}*** |
|                       |                       | after entry into     |
|                       |                       | force of this        |
|                       |                       | Regulation.          |
|                       |                       |                      |
|                       |                       | \*\* Date of entry   |
|                       |                       | into force of this   |
|                       |                       | Regulation.          |
|                       |                       |                      |
|                       |                       | \*\*\* 6 years after |
|                       |                       | entry into force of  |
|                       |                       | this Regulation      |
|                       |                       |                      |
|                       |                       | \*\*\*\* 11 years    |
|                       |                       | after entry into     |
|                       |                       | force of this        |
|                       |                       | Regulation           |
|                       |                       |                      |
|                       |                       | \_\_\_\_\_\_         |
|                       |                       | \_\_\_\_\_\_\_\_\_\_ |
|                       |                       |                      |
|                       |                       | [As a consequence of |
|                       |                       | the postponement of  |
|                       |                       | the deadline of the  |
|                       |                       | dead line the        |
|                       |                       | following changes    |
|                       |                       | will be introduced   |
|                       |                       | into other           |
|                       |                       | Ar                   |
|                       |                       | ticles:]{.underline} |
|                       |                       |                      |
|                       |                       | Article 7\           |
|                       |                       | Registration and     |
|                       |                       | notification of      |
|                       |                       | substances in        |
|                       |                       | articles             |
|                       |                       |                      |
|                       |                       | ............         |
|                       |                       |                      |
|                       |                       | 7\. From ....\*      |
|                       |                       | paragraphs 2, 3 and  |
|                       |                       | 4 of this Article    |
|                       |                       | shall apply 6 months |
|                       |                       | after a substance is |
|                       |                       | identified in        |
|                       |                       | accordance with      |
|                       |                       | Article 58(1).       |
|                       |                       |                      |
|                       |                       | [\*]{.smallcaps}     |
|                       |                       | **48** months after  |
|                       |                       | entry into force of  |
|                       |                       | this Regulation.     |
|                       |                       |                      |
|                       |                       | Article 42\          |
|                       |                       | Procedure and time   |
|                       |                       | periods for          |
|                       |                       | examination of       |
|                       |                       | testing proposals    |
|                       |                       |                      |
|                       |                       | 1\. In the case of   |
|                       |                       | non phase-in         |
|                       |                       | substances, the      |
|                       |                       | Agency shall prepare |
|                       |                       | a draft decision in  |
|                       |                       | accordance with      |
|                       |                       | Article 39(2) within |
|                       |                       | 180 days of          |
|                       |                       | receiving a          |
|                       |                       | registration or      |
|                       |                       | downstream user      |
|                       |                       | report containing a  |
|                       |                       | testing proposal.    |
|                       |                       |                      |
|                       |                       | 2\. In the case of   |
|                       |                       | phase-in substances, |
|                       |                       | the Agency shall     |
|                       |                       | prepare the draft    |
|                       |                       | decisions in         |
|                       |                       | accordance with      |
|                       |                       | Article 39(2):       |
|                       |                       |                      |
|                       |                       | \(a\) by \* for all  |
|                       |                       | registrations        |
|                       |                       | received by \*\*     |
|                       |                       | containing proposals |
|                       |                       | for testing in order |
|                       |                       | to fulfil the        |
|                       |                       | information          |
|                       |                       | requirements in      |
|                       |                       | Annexes IX and X;    |
|                       |                       |                      |
|                       |                       | \(b\) by \*\*\* for  |
|                       |                       | all registrations    |
|                       |                       | received by \*\*\*\* |
|                       |                       | containing proposals |
|                       |                       | for testing in order |
|                       |                       | to fulfil the        |
|                       |                       | information          |
|                       |                       | requirements in      |
|                       |                       | Annex IX only;       |
|                       |                       |                      |
|                       |                       | \(c\) by \*\*\*\*\*  |
|                       |                       | for any              |
|                       |                       | registrations        |
|                       |                       | containing testing   |
|                       |                       | proposals received   |
|                       |                       | by \*\*\*\*\*\*.     |
|                       |                       |                      |
|                       |                       | 3\. The list of      |
|                       |                       | registration         |
|                       |                       | dossiers being       |
|                       |                       | evaluated under      |
|                       |                       | Article 39 shall be  |
|                       |                       | made available to    |
|                       |                       | Member States.       |
|                       |                       |                      |
|                       |                       | \* **66 months**     |
|                       |                       | after entry into     |
|                       |                       | force of this        |
|                       |                       | Regulation.          |
|                       |                       |                      |
|                       |                       | \*\* **42 moths**    |
|                       |                       | after entry into     |
|                       |                       | force of this        |
|                       |                       | Regulation.          |
|                       |                       |                      |
|                       |                       | \*\*\* 9 years after |
|                       |                       | entry into force of  |
|                       |                       | this Regulation.     |
|                       |                       |                      |
|                       |                       | \*\*\*\* 6 years     |
|                       |                       | after entry into     |
|                       |                       | force of this        |
|                       |                       | Regulation.          |
|                       |                       |                      |
|                       |                       | \*\*\*\*\* 15 years  |
|                       |                       | after entry into     |
|                       |                       | force of this        |
|                       |                       | Regulation.          |
|                       |                       |                      |
|                       |                       | \*\*\*\*\*\*11 years |
|                       |                       | after entry into     |
|                       |                       | force of this        |
|                       |                       | Regulation.          |
|                       |                       |                      |
|                       |                       | Article 43\          |
|                       |                       | Criteria for         |
|                       |                       | substance evaluation |
|                       |                       |                      |
|                       |                       | .........            |
|                       |                       |                      |
|                       |                       | 2\. The Agency shall |
|                       |                       | use the criteria in  |
|                       |                       | paragraph 1 for the  |
|                       |                       | purpose of compiling |
|                       |                       | a draft Community    |
|                       |                       | rolling action plan  |
|                       |                       | which shall cover a  |
|                       |                       | period of three      |
|                       |                       | years and shall      |
|                       |                       | specify substances   |
|                       |                       | to be evaluated each |
|                       |                       | year. Substances     |
|                       |                       | shall be included if |
|                       |                       | there are grounds    |
|                       |                       | for considering      |
|                       |                       | (either on the basis |
|                       |                       | of a dossier         |
|                       |                       | evaluation carried   |
|                       |                       | out by the Agency or |
|                       |                       | on the basis of any  |
|                       |                       | other appropriate    |
|                       |                       | source, including    |
|                       |                       | information in the   |
|                       |                       | registration         |
|                       |                       | dossier) that a      |
|                       |                       | given substance      |
|                       |                       | constitutes a risk   |
|                       |                       | to human health or   |
|                       |                       | the environment. The |
|                       |                       | Agency shall submit  |
|                       |                       | the first draft      |
|                       |                       | rolling action plan  |
|                       |                       | to the Member States |
|                       |                       | by ...**^\*^**. The  |
|                       |                       | Agency shall submit  |
|                       |                       | draft annual updates |
|                       |                       | to the rolling       |
|                       |                       | action plan to the   |
|                       |                       | Member States by 28  |
|                       |                       | February each year.  |
|                       |                       |                      |
|                       |                       | The Agency shall     |
|                       |                       | adopt the final      |
|                       |                       | Community rolling    |
|                       |                       | action plan on the   |
|                       |                       | basis of an opinion  |
|                       |                       | from the Member      |
|                       |                       | State Committee set  |
|                       |                       | up under Article     |
|                       |                       | 75(1)(e)             |
|                       |                       | (hereinafter         |
|                       |                       | referred to as \"the |
|                       |                       | Member State         |
|                       |                       | Committee\") and     |
|                       |                       | shall publish the    |
|                       |                       | plan on its website, |
|                       |                       | identifying the      |
|                       |                       | Member State who     |
|                       |                       | will carry out the   |
|                       |                       | evaluation of the    |
|                       |                       | substances listed    |
|                       |                       | therein as           |
|                       |                       | determined according |
|                       |                       | to Article 44.       |
|                       |                       |                      |
|                       |                       | \* **54 months**     |
|                       |                       | after entry into     |
|                       |                       | force of this        |
|                       |                       | Regulation.          |
|                       |                       |                      |
|                       |                       | Article 115\         |
|                       |                       | Transitional         |
|                       |                       | arrangements         |
|                       |                       |                      |
|                       |                       | The obligations set  |
|                       |                       | out in Article 112   |
|                       |                       | shall apply from     |
|                       |                       | ...\*\*.             |
|                       |                       |                      |
|                       |                       | \*\* ~~3 years~~     |
|                       |                       | ***42 months***      |
|                       |                       | after entry into     |
|                       |                       | force of this        |
|                       |                       | Regulation.          |
|                       |                       |                      |
|                       |                       | ^(#)^ *an error in   |
|                       |                       | the text of the      |
|                       |                       | Common Position*     |
+-----------------------+-----------------------+----------------------+

+-----------------------+-----------------------+----------------------+
| Article 14.1 subpara  | Amendment 46          | It was agreed that   |
| 1                     |                       | paragraph 1 of       |
|                       | 1\. Without prejudice | Article 137 should   |
| 1\. Without prejudice | to Article 4 of       | be modified as       |
| to Article 4 of       | Directive 98/24/EC, a | follows:             |
| Directive 98/24/EC, a | chemical safety       |                      |
| chemical safety       | assessment shall be   | 1\. By ...\*, the    |
| assessment shall be   | performed and a       | Commission shall     |
| performed and a       | chemical safety       | carry out a review   |
| chemical safety       | report completed for  | to assess whether or |
| report completed for  | all substances        | not to extend the    |
| all substances        | subject to            | application of the   |
| subject to            | registration in       | obligation to        |
| registration in       | accordance with this  | perform a chemical   |
| accordance with this  | Chapter.              | safety assessment    |
| Chapter if the        |                       | and to document it   |
| registrant            |                       | in a chemical safety |
| manufactures or       |                       | report to substances |
| imports such a        |                       | not covered by this  |
| substance in          |                       | obligation because   |
| quantities of 10      |                       | they are not subject |
| tonnes or more per    |                       | to registration or   |
| year.                 |                       | subject to           |
|                       |                       | registration but     |
|                       |                       | manufactured or      |
|                       |                       | imported in          |
|                       |                       | quantities of less   |
|                       |                       | than 10 tonnes per   |
|                       |                       | year. ***However,    |
|                       |                       | for substances       |
|                       |                       | meeting the criteria |
|                       |                       | for classification   |
|                       |                       | as carcinogenic,     |
|                       |                       | mutagenic or toxic   |
|                       |                       | for reproduction,    |
|                       |                       | category 1 or 2, in  |
|                       |                       | accordance with      |
|                       |                       | D                    |
|                       |                       | irective 67/548/EEC, |
|                       |                       | the review shall be  |
|                       |                       | carried out by       |
|                       |                       | ...\*\*. When        |
|                       |                       | carrying out the     |
|                       |                       | review the           |
|                       |                       | Commission shall     |
|                       |                       | take into account    |
|                       |                       | all relevant         |
|                       |                       | factors,             |
|                       |                       | including:***        |
|                       |                       |                      |
|                       |                       | ***1) costs for the  |
|                       |                       | manufacturers and    |
|                       |                       | importers for the    |
|                       |                       | chemical safety      |
|                       |                       | reports***           |
|                       |                       |                      |
|                       |                       | ***2) distribution   |
|                       |                       | of costs between     |
|                       |                       | actors in the supply |
|                       |                       | chain and the        |
|                       |                       | downstream user***   |
|                       |                       |                      |
|                       |                       | ***3) benefits for   |
|                       |                       | the human health and |
|                       |                       | the environment.***  |
|                       |                       |                      |
|                       |                       | ***On the basis of   |
|                       |                       | these reviews, the   |
|                       |                       | Commission may, if   |
|                       |                       | appropriate, present |
|                       |                       | legislative          |
|                       |                       | proposals to extend  |
|                       |                       | this obligation.***  |
|                       |                       |                      |
|                       |                       | \* 12 years after    |
|                       |                       | entry into force of  |
|                       |                       | this Regulation.     |
|                       |                       |                      |
|                       |                       | \*\* 7 years after   |
|                       |                       | entry into force of  |
|                       |                       | this Regulation.     |
+-----------------------+-----------------------+----------------------+
| Article 23 a          | Amendment 51          | It was agreed that   |
|                       |                       | Amendment 51 should  |
| Does not exist.       | ***Article 23a***     | be addressed in the  |
|                       |                       | context of Amendment |
|                       | ***Notification of    | 55 and by            |
|                       | intention not to      | introducing a new    |
|                       | register a            | recital as follows:  |
|                       | substance***          |                      |
|                       |                       | ***Recital (new):*** |
|                       | ***1. Manufacturers   |                      |
|                       | or importers of a     | ***Manufacturers and |
|                       | substance, either on  | importers of a       |
|                       | its own or in a       | substance on its own |
|                       | preparation, who do   | or in a preparation  |
|                       | not intend to submit  | should be encouraged |
|                       | an application for    | to communicate with  |
|                       | registration of the   | their downstream     |
|                       | substance shall       | users of the         |
|                       | notify the Agency and | substance with       |
|                       | downstream users of   | regard to whether    |
|                       | their intention.***   | they intend to       |
|                       |                       | register the         |
|                       | ***2. The             | substance. Such      |
|                       | notification referred | information should   |
|                       | to in paragraph 1     | be provided to a     |
|                       | shall be forwarded*** | downstream user      |
|                       |                       | sufficiently in      |
|                       | ***(a) 12 months      | advance of the       |
|                       | before the deadline   | relevant             |
|                       | laid down in Article  | registration         |
|                       | 23(1) for phase-in    | dead-line if the     |
|                       | substances            | manufacturer or      |
|                       | manufactured or       | importer does not    |
|                       | imported in           | intend to register   |
|                       | quantities reaching 1 | the substance in     |
|                       | 000 tonnes or more    | order for the        |
|                       | per year;***          | downstream user to   |
|                       |                       | look for alternative |
|                       | ***(b) 24 months      | sources of           |
|                       | before the deadline   | supply.***           |
|                       | laid down in Article  |                      |
|                       | 23(2) for phase-in    |                      |
|                       | substances            |                      |
|                       | manufactured or       |                      |
|                       | imported in           |                      |
|                       | quantities reaching   |                      |
|                       | 100 tonnes or more    |                      |
|                       | per year;***          |                      |
|                       |                       |                      |
|                       | ***(c) 36 months      |                      |
|                       | before the deadline   |                      |
|                       | laid down in Article  |                      |
|                       | 23(3) for phase-in    |                      |
|                       | substances            |                      |
|                       | manufactured or       |                      |
|                       | imported in           |                      |
|                       | quantities reaching 1 |                      |
|                       | tonne or more per     |                      |
|                       | year.***              |                      |
|                       |                       |                      |
|                       | ***3. Should the      |                      |
|                       | manufacturer or       |                      |
|                       | importer fail to      |                      |
|                       | notify the Agency or  |                      |
|                       | downstream users of   |                      |
|                       | his intention not to  |                      |
|                       | register the          |                      |
|                       | substance, he shall   |                      |
|                       | be required to submit |                      |
|                       | a registration        |                      |
|                       | application for the   |                      |
|                       | substance.***         |                      |
+-----------------------+-----------------------+----------------------+
| Article 25.3          | Amendment 169         | It was agreed to     |
|                       | (ENVI) + two other    | amend Article 25.3   |
| 3\. Any study         | articles with the     | as follows:          |
| summaries or robust   | same reference        |                      |
| study summaries of    |                       | *3. Any study        |
| studies submitted in  | 3\. Any study         | summaries or robust  |
| the framework of a    | summaries or robust   | study summaries of   |
| registration under    | study summaries of    | studies submitted in |
| this Regulation at    | studies relating to   | the framework of a   |
| least ***10*** years  | both animal and       | registration under   |
| previously can be     | non-animal tests      | this Regulation at   |
| used for the purposes | submitted in the      | least                |
| of registration by    | framework of a        | **[12]{.underline}** |
| another manufacturer  | registration under    | years previously can |
| or importer.          | this Regulation at    | be used for the      |
|                       | least ***15*** years  | purposes of          |
|                       | previously may be     | registration by      |
|                       | made freely available | another manufacturer |
|                       | by the Agency to any  | or importer.*        |
|                       | other registrants or  |                      |
|                       | potential             | *Consequently,       |
|                       | registrants.          | change [10 years to  |
|                       |                       | 12]{.underline}      |
|                       |                       | years in Article     |
|                       |                       | 26.3 and Article     |
|                       |                       | 27.1.*               |
+-----------------------+-----------------------+----------------------+

+-----------------------+-----------------------+----------------------+
| Article 27.6          | Amendment 52          | It was agreed that   |
|                       |                       | the text be modified |
| 6\. Within one month  | 6\. Within one month  | as follows:          |
| from the receipt of   | from the receipt of   |                      |
| the information       | the information       | 6\. Within one month |
| referred to in        | referred to in        | from the receipt of  |
| paragraph 5, the      | paragraph 5***,***    | the information      |
| Agency shall give the | the Agency shall give | referred to in       |
| potential registrant  | the potential         | paragraph 5, the     |
| permission to refer   | registrant permission | Agency shall give    |
| to the information    | to refer to the       | the potential        |
| requested by him in   | information requested | registrant           |
| his registration      | by him in his         | permission to refer  |
| dossier. Provided he  | registration dossier. | to the information   |
| makes the full study  | Provided he makes the | requested by him in  |
| report available to   | full study report     | his registration     |
| the potential         | available to the      | dossier ***subject   |
| registrant, the       | potential registrant, | to the potential     |
| previous              | the previous          | registrant           |
| registrant(s) shall   | registrant(s) shall   | providing, upon      |
| have a claim on the   | have a claim on the   | request by the       |
| potential registrant  | potential registrant  | Agency, proof that   |
| for an equal share of | for ***a fair***      | he has paid the      |
| the cost incurred by  | share of the cost     | previous             |
| him, which shall be   | incurred by him,      | registrant(s) for    |
| enforceable in the    | which shall be        | that information, a  |
| national courts.      | enforceable in the    | share of cost        |
|                       | national courts.      | incurred. The        |
|                       |                       | previous             |
|                       | ***The sharing of the | registrant(s) shall  |
|                       | actual costs incurred | have a claim on the  |
|                       | by the original       | potential registrant |
|                       | registrant(s) for the | for a proportionate  |
|                       | study concerned shall | share of the cost    |
|                       | be calculated in a    | incurred by him.     |
|                       | way which is          | Calculation of the   |
|                       | proportional to each  | proportionate share  |
|                       | party's               | may be facilitated   |
|                       | production/import     | by the guidance      |
|                       | volume.***            | adopted by the       |
|                       |                       | Agency in accordance |
|                       | ***Where the original | with Article         |
|                       | total cost has        | 76(2)(f).***         |
|                       | already been shared   | Provided he makes    |
|                       | between two or more   | the full study       |
|                       | registrants, any      | report available to  |
|                       | subsequent potential  | the potential        |
|                       | registrant(s) shall   | registrant, the      |
|                       | pay each registrant a | previous             |
|                       | fair share of his     | registrant(s) shall  |
|                       | contribution to       | have a claim on the  |
|                       | costs.***             | potential registrant |
|                       |                       | for an equal share   |
|                       |                       | of the cost incurred |
|                       |                       | by him, which shall  |
|                       |                       | be enforceable in    |
|                       |                       | the national courts. |
+-----------------------+-----------------------+----------------------+
| Article 28.2 a        | Amendment 55          | The contents of this |
|                       |                       | amendment were       |
| Does not exist.       | ***2a. If the period  | agreed, but the      |
|                       | referred to in        | order of paragraphs  |
| ***5***. The Agency   | paragraph 2 has       | will be changed, a   |
| shall by ...\*        | elapsed, the Agency   | new paragraph 5      |
| publish on its        | shall, upon request   | introduced and       |
| website a list of the | by a downstream user  | paragraph 6 (former  |
| substances refered to | of a substance that   | 4) reworded. An      |
| in paragraph 1(a) and | has not been          | additional sentence  |
| (d). That list shall  | pre-registered,       | in Recital 50 in     |
| comprise only the     | permit late           | connection to        |
| names of subtances    | notification to the   | Amendment 58 was     |
| including their       | register of           | agreed as a          |
| EINECS and CAS number | substances by any     | consequence. The     |
| if available and      | person other than the | modified text in     |
| other identity codes. | original supplier of  | Article 28 responds  |
|                       | that substance to the | also to Amendment    |
| ***4***. Potential    | downstream user for a | 51.                  |
| registrants who       | further six months    |                      |
| manufacture or import | after the publication | *Article 28*         |
| for the first time a  | of the register. Such |                      |
| phase-in substance in | notification shall    | *Duty to             |
| quantities of 1 tonne | enable the potential  | pre-register for     |
| or more per year      | registrant to benefit | phase in substances* |
| after ...\*\*, shall  | from the transitional |                      |
| be entitled to rely   | regime set out in     | \[1-3 unchanged.\]   |
| on Article 23         | Chapter 5 of Title    |                      |
| provided that they    | II.***                | ***4***. The Agency  |
| submit the            |                       | shall by ...\*       |
| information referred  |                       | publish on its       |
| to in paragraph 1 of  |                       | website a list of    |
| this Article to the   |                       | the substances       |
| Agency within six     |                       | refered to in        |
| months of first       |                       | paragraph 1(a) and   |
| manufacturing or      |                       | (d). That list shall |
| importing the         |                       | comprise only the    |
| substance and no      |                       | names of subtances   |
| later than 12 months  |                       | including their      |
| before the relevant   |                       | EINECS and CAS       |
| deadline in Article   |                       | number if available  |
| 23.                   |                       | and other identity   |
|                       |                       | codes.               |
| ***6.***              |                       |                      |
| Manufacturers or      |                       | ***5. After the      |
| importers of phase-in |                       | publication of the   |
| substances in         |                       | list a downstream    |
| quantities of less    |                       | user of a substance  |
| than 1 tonne per year |                       | not appearing on the |
| that appear on the    |                       | list may notify the  |
| list published by the |                       | Agency of his        |
| Agency in accordance  |                       | interest in the      |
| with paragraph 5 of   |                       | substance, his       |
| this Article, as well |                       | contact details and  |
| as downstream users   |                       | the details of his   |
| of those substances   |                       | current supplier.    |
| and third parties     |                       | The Agency shall     |
| holding information   |                       | publish on its       |
| on those substances,  |                       | website the name of  |
| may submit the        |                       | the substance and on |
| information referred  |                       | request provide      |
| to in paragraph 1 of  |                       | contact details of   |
| this Article or any   |                       | the downstream user  |
| other relevant        |                       | to a potential       |
| information to the    |                       | registrant.***       |
| Agency for those      |                       |                      |
| substances, with the  |                       | ***6***. Potential   |
| intention of being    |                       | registrants who      |
| part of the substance |                       | manufacture or       |
| information exchange  |                       | import for the first |
| forum as referred to  |                       | time a phase-in      |
| in Article 29.        |                       | substance in         |
|                       |                       | quantities of 1      |
|                       |                       | tonne or more per    |
|                       |                       | year after ...\*\*,  |
|                       |                       | shall be entitled to |
|                       |                       | rely on Article 23   |
|                       |                       | provided that they   |
|                       |                       | submit the           |
|                       |                       | information referred |
|                       |                       | to in paragraph 1 of |
|                       |                       | this Article to the  |
|                       |                       | Agency within six    |
|                       |                       | months of first      |
|                       |                       | manufacturing or     |
|                       |                       | importing the        |
|                       |                       | substance ***in      |
|                       |                       | quantities of 1      |
|                       |                       | tonne or more per    |
|                       |                       | year*** and no later |
|                       |                       | than 12 months       |
|                       |                       | before the relevant  |
|                       |                       | deadline in Article  |
|                       |                       | 23.                  |
|                       |                       |                      |
|                       |                       | ***7.***             |
|                       |                       | Manufacturers or     |
|                       |                       | importers of         |
|                       |                       | phase-in substances  |
|                       |                       | in quantities of     |
|                       |                       | less than 1 tonne    |
|                       |                       | per year that appear |
|                       |                       | on the list          |
|                       |                       | published by the     |
|                       |                       | Agency in accordance |
|                       |                       | with paragraph 5 of  |
|                       |                       | this Article, as     |
|                       |                       | well as downstream   |
|                       |                       | users of those       |
|                       |                       | substances and third |
|                       |                       | parties holding      |
|                       |                       | information on those |
|                       |                       | substances, may      |
|                       |                       | submit the           |
|                       |                       | information referred |
|                       |                       | to in paragraph 1 of |
|                       |                       | this Article or any  |
|                       |                       | other relevant       |
|                       |                       | information to the   |
|                       |                       | Agency for those     |
|                       |                       | substances, with the |
|                       |                       | intention of being   |
|                       |                       | part of the          |
|                       |                       | substance            |
|                       |                       | information exchange |
|                       |                       | forum as referred to |
|                       |                       | in Article 29.       |
+-----------------------+-----------------------+----------------------+

+-----------------------+-----------------------+----------------------+
| Article 29            | Amendment 58          | It was agreed that   |
|                       |                       | the text of Article  |
| 1\. All manufacturers | 1\. All               | 29.1 should be       |
| and importers who     | manufacturers***,***  | modified in respond  |
| have submitted        | importers ***and      | to proposed          |
| information to the    | formulators*** who    | amendments           |
| Agency in accordance  | have submitted        | concerning the first |
| with Article 28 for   | information to the    | sub-paragraph of     |
| the same phase-in     | Agency in accordance  | Article 30.1 to read |
| substance shall be    | with Article 28 for   | as follows.          |
| participants in a     | the same phase-in     | Consequently Recital |
| substance information | substance shall be    | 50 will also be      |
| exchange forum        | participants in a     | modified:            |
| (SIEF).               | substance information |                      |
|                       | exchange forum        | 1\. All ***potential |
| 2\. The aim of each   | (SIEF).               | registrants,         |
| SIEF shall be to:     |                       | downstream users and |
|                       |                       | third parties*** who |
| \(a\) facilitate, for |                       | have submitted       |
| the purposes of       |                       | information to the   |
| registration, the     |                       | Agency in accordance |
| exchange of the       |                       | with Article 28**,   |
| information specified |                       | *or whose            |
| in Article 10(a) (vi) |                       | information is held  |
| and (vii) between     |                       | by the Agency in     |
| manufacturers and     |                       | accordance with      |
| importers, thereby    |                       | Article 15*,** for   |
| avoiding the          |                       | the same phase-in    |
| duplication of        |                       | substance**, *or     |
| studies; and          |                       | registrants who have |
|                       |                       | submitted a          |
| \(b\) agree           |                       | registration for     |
| classification and    |                       | that phase-in        |
| labelling where there |                       | substance before the |
| is a difference in    |                       | deadline in Article  |
| the classification    |                       | 23(3),*** shall be   |
| and labelling of the  |                       | participants in a    |
| substance.            |                       | substance            |
|                       |                       | information exchange |
| 3\. SIEF participants |                       | forum (SIEF).        |
| shall provide other   |                       |                      |
| participants with     |                       | 2\. The aim of each  |
| existing studies,     |                       | SIEF shall be to:    |
| react to requests by  |                       |                      |
| other participants    |                       | \(a\) facilitate,    |
| for information,      |                       | for the purposes of  |
| collectively identify |                       | registration, the    |
| needs for further     |                       | exchange of the      |
| studies and arrange   |                       | information          |
| for them to be        |                       | specified in Article |
| carried out. Each     |                       | 10(a) (vi) and (vii) |
| SIEF shall be         |                       | between ***potential |
| operational until     |                       | registrants***,      |
| ...\*                 |                       | thereby avoiding the |
|                       |                       | duplication of       |
|                       |                       | studies; and         |
|                       |                       |                      |
|                       |                       | \(b\) agree          |
|                       |                       | classification and   |
|                       |                       | labelling where      |
|                       |                       | there is a           |
|                       |                       | difference in the    |
|                       |                       | classification and   |
|                       |                       | labelling of the     |
|                       |                       | substance ***between |
|                       |                       | potential            |
|                       |                       | registrants***.      |
|                       |                       |                      |
|                       |                       | 3\. SIEF             |
|                       |                       | participants shall   |
|                       |                       | provide other        |
|                       |                       | participants with    |
|                       |                       | existing studies,    |
|                       |                       | react to requests by |
|                       |                       | other participants   |
|                       |                       | for information,     |
|                       |                       | collectively         |
|                       |                       | identify needs for   |
|                       |                       | further studies      |
|                       |                       | ***for the purposes  |
|                       |                       | of paragraph 2       |
|                       |                       | (a)*** and arrange   |
|                       |                       | for ***such          |
|                       |                       | studies*** to be     |
|                       |                       | carried out . Each   |
|                       |                       | SIEF shall be        |
|                       |                       | operational until    |
|                       |                       | ...\*.               |
|                       |                       |                      |
|                       |                       | \* 11 years after    |
|                       |                       | entry into force of  |
|                       |                       | this Regulation.     |
|                       |                       |                      |
|                       |                       | \_\_\_\_\_           |
|                       |                       |                      |
|                       |                       | Recital 50:          |
|                       |                       |                      |
|                       |                       | In order to avoid    |
|                       |                       | duplication of work, |
|                       |                       | and in particular to |
|                       |                       | avoid duplication of |
|                       |                       | testing, registrants |
|                       |                       | of phase-in          |
|                       |                       | substances should    |
|                       |                       | pre-register as      |
|                       |                       | early as possible    |
|                       |                       | with a database      |
|                       |                       | managed by the       |
|                       |                       | Agency. A system     |
|                       |                       | should be            |
|                       |                       | established to       |
|                       |                       | provide for          |
|                       |                       | Substance            |
|                       |                       | Information Exchange |
|                       |                       | Fora (SIEF) to help  |
|                       |                       | ***exchange of       |
|                       |                       | information on the   |
|                       |                       | substances that have |
|                       |                       | been registered.***  |
|                       |                       | ***SIEF participants |
|                       |                       | should include all   |
|                       |                       | relevant actors      |
|                       |                       | submitting           |
|                       |                       | information to the   |
|                       |                       | Agency on the same   |
|                       |                       | phase-in             |
|                       |                       | substance.** **They  |
|                       |                       | should include both  |
|                       |                       | potential            |
|                       |                       | registrants, who     |
|                       |                       | must provide and be  |
|                       |                       | supplied with any    |
|                       |                       | information relevant |
|                       |                       | to the registration  |
|                       |                       | of their substances, |
|                       |                       | and other            |
|                       |                       | participants, who    |
|                       |                       | may receive          |
|                       |                       | financial            |
|                       |                       | compensation for     |
|                       |                       | studies they hold    |
|                       |                       | but are not entitled |
|                       |                       | to request           |
|                       |                       | informati            |
|                       |                       | on[.]{.underline}*** |
|                       |                       | In order to ensure   |
|                       |                       | the smooth           |
|                       |                       | functioning of that  |
|                       |                       | system they should   |
|                       |                       | fulfil certain       |
|                       |                       | obligations. If a    |
|                       |                       | member of a SIEF     |
|                       |                       | does not fulfil his  |
|                       |                       | obligations, he      |
|                       |                       | should be penalised  |
|                       |                       | accordingly but      |
|                       |                       | other members should |
|                       |                       | be enabled to        |
|                       |                       | continue preparing   |
|                       |                       | their own            |
|                       |                       | registration. ***In  |
|                       |                       | cases where a        |
|                       |                       | substance has not    |
|                       |                       | been pre-registered, |
|                       |                       | measures should be   |
|                       |                       | taken to help        |
|                       |                       | downstream users     |
|                       |                       | find alternative     |
|                       |                       | sources of           |
|                       |                       | supply.***           |
+-----------------------+-----------------------+----------------------+
| Article 30.1          | Amendment 59          | The proposed         |
|                       |                       | amendments to the    |
| 1\. Before testing is | 1\. Before testing is | first sub-paragraph  |
| carried out in order  | carried out in order  | are addressed in the |
| to meet the           | to meet the           | response to          |
| information           | information           | Amendment 58. It was |
| requirements for the  | requirements for the  | agreed to modify     |
| purposes of           | purposes of           | Article 30.1 as      |
| registration, a SIEF  | registration, a SIEF  | follows:             |
| participant shall     | participant shall     |                      |
| inquire whether a     | inquire whether a     | 1\. Before testing   |
| relevant study is     | relevant study is     | is carried out in    |
| available by          | available by          | order to meet the    |
| communicating within  | communicating within  | information          |
| his SIEF. If a        | his SIEF ***and       | requirements for the |
| relevant study        | consulting the lists  | purposes of          |
| involving tests on    | published by the      | registration, a SIEF |
| vertebrate animals is | Agency in accordance  | participant shall    |
| available within the  | with Article 28(5)    | inquire whether a    |
| SIEF, a participant   | and (5a)***. If a     | relevant study is    |
| of that SIEF shall    | relevant study        | available by         |
| request that study    | involving tests is    | communicating within |
| ***by ...\*\*.*** If  | available, a          | his SIEF. If a       |
| a relevant study not  | participant of SIEF   | relevant study       |
| involving tests on    | shall request that    | involving tests on   |
| vertebrate animals is | study.                | vertebrate animals   |
| available within the  |                       | is available within  |
| SIEF, a SIEF          | Within ***one         | the SIEF, a          |
| participant may       | month*** of the       | participant of that  |
| request that study    | request, the owner of | SIEF shall request   |
| ***by ....\*\****     | the study shall       | that study. If a     |
|                       | provide proof of its  | relevant study not   |
| Within two weeks of   | cost to the           | involving tests on   |
| the request, the      | participant(s)        | vertebrate animals   |
| owner of the study    | requesting it. The    | is available within  |
| shall provide proof   | participant(s) and    | the SIEF, a SIEF     |
| of its cost to the    | the owner shall make  | participant may      |
| participant(s)        | every effort to       | request that study.  |
| requesting it. The    | ensure that the costs |                      |
| participant(s) and    | of sharing the        | Within **one month** |
| the owner shall make  | information are       | of the request, the  |
| every effort to       | determined in a fair, | owner of the study   |
| ensure that the costs | transparent and non   | shall provide proof  |
| of sharing the        | discriminatory way    | of its cost to the   |
| information are       | ***and in proportion  | participant(s)       |
| determined in a fair, | to each party's       | requesting it. The   |
| transparent and non   | production volume***. | participant(s) and   |
| discriminatory way.   | This may be           | the owner shall make |
| This may be           | facilitated by        | every effort to      |
| facilitated by        | following any cost    | ensure that the      |
| following any cost    | sharing guidance      | costs of sharing the |
| sharing guidance      | which is based on     | information are      |
| which is based on     | those principles and  | determined in a      |
| those principles and  | is adopted by the     | fair, transparent    |
| is adopted by the     | Agency in accordance  | and non              |
| Agency in accordance  | with Article          | discriminatory way.  |
| with Article          | 76(2)(f). If they     | This may be          |
| 76(2)(f). If they     | cannot reach such an  | facilitated by       |
| cannot reach such an  | agreement, the cost   | following any cost   |
| agreement, the cost   | shall be shared ***in | sharing guidance     |
| shall be shared       | a fair way***. The    | which is based on    |
| equally. The owner    | owner shall give      | those principles and |
| shall give permission | permission to refer   | is adopted by the    |
| to refer to the full  | to the full study     | Agency in accordance |
| study report for the  | report for the        | with Article         |
| purpose of            | purpose of            | 73(2)(f). If they    |
| registration within   | registration within   | cannot reach such an |
| two weeks of receipt  | two weeks of receipt  | agreement, the cost  |
| of payment.           | of payment.           | shall be shared      |
| Registrants are only  | Registrants are only  | equally. The owner   |
| required to share in  | required to share in  | shall give           |
| the costs of          | the costs of          | permission to refer  |
| information that they | information that they | to the full study    |
| are required to       | are required to       | report for the       |
| submit to satisfy     | submit to satisfy     | purpose of           |
| their registration    | their registration    | registration within  |
| requirements.         | requirements.         | two weeks of receipt |
|                       |                       | of payment.          |
| \_\_\_\_\_\_\_\_      |                       | Registrants are only |
|                       |                       | required to share in |
| ***\*\* 20 months     |                       | the costs of         |
| after entry into      |                       | information that     |
| force of this         |                       | they are required to |
| Regulation.***        |                       | submit to satisfy    |
|                       |                       | their registration   |
|                       |                       | requirements.        |
+-----------------------+-----------------------+----------------------+

+-----------------------+-----------------------+----------------------+
| ANNEX VIII, COLUMNS 1 | Amendment 345 (as     | It was agreed that   |
| AND 2, POINT 8.4.2    | tabled for ENVI       | point 8.4.2 should   |
| AND 8.4.3             | Committee)            | be modified as       |
|                       |                       | follows:             |
| Column 1              | Column 1              |                      |
|                       |                       | Column 1             |
| 8.4.2. In vitro       | 8.4.2. In vitro       |                      |
| cytogenicity study in | cytogenicity study in | 8.4.2. In vitro      |
| mammalian cells       | mammalian cells ***or | cytogenicity study   |
|                       | in vitro micronucleus | in mammalian cells   |
| Column 2              | study***              | ***or in vitro       |
|                       |                       | micronucleus         |
| 8.4.2. The study does | Column 2              | study***             |
| not usually need to   |                       |                      |
| be conducted          | **8.4.2 *These        | Column 2             |
|                       | studies (8.4.2 and    |                      |
| \- if adequate data   | 8.4.3) do not         | 8.4.2. The study     |
| from an *in vivo*     | usually*** need to be | does not usually     |
| cytogenicity test are | conducted             | need to be conducted |
| available or          |                       |                      |
|                       | **-** if adequate     | \- if adequate data  |
| \- the substance is   | data from an in vivo  | from an *in vivo*    |
| known to be           | test are available or | cytogenicity test    |
| carcinogenic          |                       | are available or     |
| category 1 or 2 or    | **-** the substance   |                      |
| mutagenic category 1, | is known to be        | \- the substance is  |
| 2 or 3.               | carcinogenic          | known to be          |
|                       | category 1 or 2 or    | carcinogenic         |
| Column 2              | mutagenic category 1, | category 1 or 2 or   |
|                       | 2 or 3, ***or the     | mutagenic category   |
| 8.4.3. The study does | registrant implements | 1, 2 or 3.           |
| not usually need to   | and, where necessary, |                      |
| be conducted if       | recommends risk       | Column 2             |
| adequate data from a  | management measure as |                      |
| reliable in vivo      | if this were the      | 8.4.3. The study     |
| mammalian gene        | case; or***           | does not usually     |
| mutation test are     |                       | need to be conducted |
| available.            | **- *the chemical     | if adequate data     |
|                       | safety assessment     | from a reliable in   |
| 8.4. Appropriate *in  | pursuant to Annex I   | vivo mammalian gene  |
| vivo* mutagenicity    | indicates that the    | mutation test are    |
| studies ***shall be   | risk to               | available.           |
| considered in case of | health/environment    |                      |
| a positive result in  | with regard to        | Appropriate *in      |
| any of the            | exposure for the      | vivo* mutagenicity   |
| genotoxicity          | identified uses is    | studies shall be     |
| studies*** in         | not relevant or is    | considered in case   |
| Annex VII or VIII.    | adequately            | of a positive result |
|                       | controlled, taking    | in any of the        |
|                       | into account risk     | genotoxicity studies |
|                       | management measures.  | in Annex VII or      |
|                       | Annex XI.3            | VIII.                |
|                       | applies.***           |                      |
|                       |                       |                      |
|                       | Column 2              |                      |
|                       |                       |                      |
|                       | 8.4.3. ***A positive  |                      |
|                       | result in any of the  |                      |
|                       | in vitro***           |                      |
|                       | mutagenicity studies  |                      |
|                       | in Annex V or VI      |                      |
|                       | ***may be confirmed   |                      |
|                       | by conducting another |                      |
|                       | in vitro test to      |                      |
|                       | confirm the likely    |                      |
|                       | mechanism and/or      |                      |
|                       | repeating the study   |                      |
|                       | together with the use |                      |
|                       | of an appropriate     |                      |
|                       | exogenous metabolic   |                      |
|                       | system (e.g., human   |                      |
|                       | microsomal            |                      |
|                       | enzymes).***          |                      |
+-----------------------+-----------------------+----------------------+
| ANNEX VIII, COLUMNS 1 | Amendment 167 (= ENVI | [It was agreed that  |
| AND 2, POINT 8.7      | 346)                  | the wording in the   |
|                       |                       | Common Position      |
| Column 1              | Column 1              | should be            |
|                       |                       | re                   |
| 8.7. Reproductive     | 8.7. Reproductive     | tained]{.underline}. |
| toxicity              | toxicity              |                      |
|                       |                       | In addition it was   |
| **8.7.1. *Screening   | 8.7.1. ***An initial  | agreed to introduce  |
| for                   | assessment of this    | review of the data   |
| repro                 | endpoint shall take   | requirements in      |
| ductive/developmental | into consideration    | ANNEX VIII, COLUMNS  |
| toxicity, one species | all*** available      | 1 AND 2, POINT 8.7   |
| (OECD 421 or 422), if | ***toxicological***   | as follows:          |
| there is no evidence  | information ***(e.g.  |                      |
| from* available       | from the 28-day or    | *Article 137*        |
| information on        | 90-day study), in     |                      |
| structurally related  | particular            | *Review*             |
| substances, from      | information*** on     |                      |
| (Q)SAR estimates or   | structurally related  | *(new) **[In         |
| from in vitro methods | substances, from      | accordance with the  |
| *that the substance   | (Q)SAR estimates or   | objective of         |
| may be a              | from in vitro         | promoting non-animal |
| developmental         | methods.              | testing and the      |
| toxicant*.**          |                       | replacement,         |
|                       | Column 2              | reduction or         |
| **Column 2**          |                       | refinement of animal |
|                       | 8.7.1 ***If the       | testing required     |
| **8.7.1. *This study  | initial assessment    | under this           |
| does not need to be   | shows that there is   | Regulation, the      |
| conducted if:***      | evidence that the     | Commission shall     |
|                       | substance may be a    | review the testing   |
| ***-- the substance   | developmental or      | requirements of      |
| is known to be a      | reproductive toxicant | Section 8.7 of Annex |
| genotoxic carcinogen  | and the company does  | VIII by^(\*)^from    |
| and appropriate risk  | not introduce and     | entry into force of  |
| management***         | recommend appropriate | this Regulation. On  |
|                       | risk management       | the basis of this    |
| ***measures are       | measures as if it     | review while         |
| implemented; or***    | were classified as    | ensuring a high      |
|                       | reprotoxic category 1 | level of protection  |
| ***-- the substance   | or 2, then suitable   | of health and the    |
| is known to be a germ | further reprotoxicity | envir                |
| cell mutagen and      | testing shall be      | onment]{.underline}, |
| appropriate risk      | performed by the      | [the Commission may  |
| management***         | registrant.***        | propose an amendment |
|                       |                       | in accordance with   |
| ***measures are       | ***The conditions     | the procedure        |
| implemented; or***    | stated for these      | referred to in       |
|                       | studies in Annex IX   | Article              |
| ***-- relevant human  | apply.***             | 132(                 |
| exposure can be       |                       | 3a).]{.underline}*** |
| excluded in           |                       |                      |
| accordance with Annex |                       | ^(\*)^***[12         |
| XI section 3; or***   |                       | y                    |
|                       |                       | ears]{.underline}*** |
| ***-- a pre-natal     |                       |                      |
| developmental         |                       |                      |
| toxicity study        |                       |                      |
| (section 8.7.2 of     |                       |                      |
| this Annex) or a      |                       |                      |
| two-generation        |                       |                      |
| reproductive toxicity |                       |                      |
| study (section 8.7.3  |                       |                      |
| of this Annex) is     |                       |                      |
| available.***         |                       |                      |
|                       |                       |                      |
| ***If a substance is  |                       |                      |
| known to have an      |                       |                      |
| adverse effect on     |                       |                      |
| fertility, meeting    |                       |                      |
| the criteria for      |                       |                      |
| classification as     |                       |                      |
| Repr Cat 1 or 2: R60, |                       |                      |
| and the available     |                       |                      |
| data are adequate to  |                       |                      |
| support a robust risk |                       |                      |
| assessment, then no   |                       |                      |
| further testing for   |                       |                      |
| fertility will be     |                       |                      |
| necessary. However,   |                       |                      |
| testing for           |                       |                      |
| development toxicity  |                       |                      |
| must be               |                       |                      |
| considered.***        |                       |                      |
|                       |                       |                      |
| ***If a substance is  |                       |                      |
| known to cause        |                       |                      |
| developmental         |                       |                      |
| toxicity, meeting the |                       |                      |
| criteria for          |                       |                      |
| classification as     |                       |                      |
| Repr Cat 1 or 2: R61, |                       |                      |
| and the available     |                       |                      |
| data are adequate to  |                       |                      |
| support a robust risk |                       |                      |
| assessment, then no   |                       |                      |
| further testing for   |                       |                      |
| developmental         |                       |                      |
| toxicity will be      |                       |                      |
| necessary. However,   |                       |                      |
| testing for effects   |                       |                      |
| on fertility must be  |                       |                      |
| considered.***        |                       |                      |
|                       |                       |                      |
| ***In cases where     |                       |                      |
| there are serious     |                       |                      |
| concerns about the    |                       |                      |
| potential for adverse |                       |                      |
| effects on fertility  |                       |                      |
| or development,       |                       |                      |
| either a pre-natal    |                       |                      |
| developmental         |                       |                      |
| toxicity study (Annex |                       |                      |
| IX, section 8.7.2) or |                       |                      |
| a two-generation      |                       |                      |
| reproductive toxicity |                       |                      |
| study (Annex IX,      |                       |                      |
| section 8.7.3) may be |                       |                      |
| proposed by the***    |                       |                      |
|                       |                       |                      |
| ***registrant instead |                       |                      |
| of the screening      |                       |                      |
| study.***             |                       |                      |
+-----------------------+-----------------------+----------------------+
| \-                    | Amendment 353 (ENVI)  | It was agreed that   |
|                       |                       | the following        |
|                       | ANNEX XI, POINT 1.5,  | sentence be added at |
|                       | PARAGRAPH 3 A (new)   | the end of Annex XI  |
|                       |                       | section 1.5.         |
|                       | The endpoints for     | (Grouping of         |
|                       | classification and    | substances and       |
|                       | for risk assessment   | read-across          |
|                       | of substances that    | approach):           |
|                       | are complex and of    |                      |
|                       | variable composition  | ***The Agency, after |
|                       | may also be           | consulting with the  |
|                       | determined from data  | relevant             |
|                       | on their              | stakeholders and     |
|                       |                       | other interested     |
|                       | significant           | parties, shall issue |
|                       | constituents using    | guidance on          |
|                       | their highest         | technically and      |
|                       | concentration in the  | scientifically       |
|                       | substance. The        | justified            |
|                       | Agency, after         | methodology for the  |
|                       | consulting relevant   | grouping of          |
|                       | stakeholders and      | substances           |
|                       | other interested      | sufficiently in      |
|                       | parties, shall issue  | advance of the first |
|                       | a detailed and        | registration         |
|                       | scientifically        | dead-line for        |
|                       | justified methodology | phase-in             |
|                       | for the grouping of   | substances.***       |
|                       | substances within     |                      |
|                       | five years from the   |                      |
|                       | adoption of this      |                      |
|                       | Regulation            |                      |
+-----------------------+-----------------------+----------------------+

**7. AUTHORISATION, INCLUDING SUBSTITUTION**

+----------------------+----------------------+----------------------+---+
| **Council Common     | **EP amendment**     | **Result of the 6th  |   |
| Position**           |                      | trilogue**           |   |
+----------------------+----------------------+----------------------+---+
| Does not exist       | Does not exist       | It was agreed, in    |   |
|                      |                      | order to respond to  |   |
|                      |                      | various amendments   |   |
|                      |                      | voted by the         |   |
|                      |                      | European Parliament, |   |
|                      |                      | that the following   |   |
|                      |                      | recitals be          |   |
|                      |                      | introduced.          |   |
|                      |                      |                      |   |
|                      |                      | ***(new 1)***        |   |
|                      |                      |                      |   |
|                      |                      | ***Substitution of a |   |
|                      |                      | substance on its     |   |
|                      |                      | own, in a            |   |
|                      |                      | preparation or in an |   |
|                      |                      | article should be    |   |
|                      |                      | required when        |   |
|                      |                      | manufacture, use or  |   |
|                      |                      | placing on the       |   |
|                      |                      | market of that       |   |
|                      |                      | substance causes an  |   |
|                      |                      | unacceptable risk to |   |
|                      |                      | human health or to   |   |
|                      |                      | the environment,     |   |
|                      |                      | taking into account  |   |
|                      |                      | the availability of  |   |
|                      |                      | suitable safer       |   |
|                      |                      | alternative          |   |
|                      |                      | substances and       |   |
|                      |                      | technologies, and    |   |
|                      |                      | the socio-economic   |   |
|                      |                      | benefits from the    |   |
|                      |                      | uses of the          |   |
|                      |                      | substance posing an  |   |
|                      |                      | unacceptable         |   |
|                      |                      | risk.***             |   |
|                      |                      |                      |   |
|                      |                      | ***Substitution of a |   |
|                      |                      | substance of very    |   |
|                      |                      | high concern by      |   |
|                      |                      | suitable alternative |   |
|                      |                      | substances or        |   |
|                      |                      | technologies should  |   |
|                      |                      | be considered by all |   |
|                      |                      | those applying for   |   |
|                      |                      | authorisations of    |   |
|                      |                      | uses of such         |   |
|                      |                      | substances on their  |   |
|                      |                      | own, in preparations |   |
|                      |                      | or for incorporation |   |
|                      |                      | of substances into   |   |
|                      |                      | articles by making   |   |
|                      |                      | an analysis of       |   |
|                      |                      | alternatives, the    |   |
|                      |                      | consequent risks of  |   |
|                      |                      | using any            |   |
|                      |                      | alternative and the  |   |
|                      |                      | technical and        |   |
|                      |                      | economic feasibility |   |
|                      |                      | of substitution.***  |   |
|                      |                      |                      |   |
|                      |                      | ***The possibility   |   |
|                      |                      | of introducing       |   |
|                      |                      | restrictions on the  |   |
|                      |                      | manufacturing,       |   |
|                      |                      | placing on the       |   |
|                      |                      | market and use of    |   |
|                      |                      | dangerous            |   |
|                      |                      | substances,          |   |
|                      |                      | preparations and     |   |
|                      |                      | articles applies to  |   |
|                      |                      | all substances       |   |
|                      |                      | falling within the   |   |
|                      |                      | scope of REACH, with |   |
|                      |                      | minor exemptions.    |   |
|                      |                      | Restrictions on the  |   |
|                      |                      | placing on the       |   |
|                      |                      | market and the use   |   |
|                      |                      | of substances which  |   |
|                      |                      | are carcinogenic,    |   |
|                      |                      | mutagenic or toxic   |   |
|                      |                      | to reproduction,     |   |
|                      |                      | categories 1 or 2    |   |
|                      |                      | for their use by     |   |
|                      |                      | consumers on their   |   |
|                      |                      | own or in            |   |
|                      |                      | preparations should  |   |
|                      |                      | continue to be       |   |
|                      |                      | introduced.***       |   |
|                      |                      |                      |   |
|                      |                      | ***(new 2)***        |   |
|                      |                      |                      |   |
|                      |                      | ***Adverse effects   |   |
|                      |                      | on human health and  |   |
|                      |                      | the environment from |   |
|                      |                      | substances of very   |   |
|                      |                      | high concern should  |   |
|                      |                      | be prevented through |   |
|                      |                      | the application of   |   |
|                      |                      | appropriate risk     |   |
|                      |                      | management measures  |   |
|                      |                      | to ensure that any   |   |
|                      |                      | risks from the uses  |   |
|                      |                      | of a substance are   |   |
|                      |                      | adequately           |   |
|                      |                      | controlled, and with |   |
|                      |                      | a view to            |   |
|                      |                      | progressively        |   |
|                      |                      | substituting these   |   |
|                      |                      | substances with a    |   |
|                      |                      | suitable safer       |   |
|                      |                      | substance. Risk      |   |
|                      |                      | management measures  |   |
|                      |                      | should be applied to |   |
|                      |                      | ensure, when         |   |
|                      |                      | substances are       |   |
|                      |                      | manufactured, placed |   |
|                      |                      | on the market and    |   |
|                      |                      | used, that exposure  |   |
|                      |                      | to these substances  |   |
|                      |                      | including            |   |
|                      |                      | discharges,          |   |
|                      |                      | emissions and        |   |
|                      |                      | losses, throughout   |   |
|                      |                      | the whole life-cycle |   |
|                      |                      | is below the         |   |
|                      |                      | threshold level      |   |
|                      |                      | beyond which adverse |   |
|                      |                      | effects may occur.   |   |
|                      |                      | For any substance    |   |
|                      |                      | for which            |   |
|                      |                      | authorisation has    |   |
|                      |                      | been granted, and    |   |
|                      |                      | for any other        |   |
|                      |                      | substance for which  |   |
|                      |                      | it is not possible   |   |
|                      |                      | to establish a safe  |   |
|                      |                      | level of exposure,   |   |
|                      |                      | measures should      |   |
|                      |                      | always be taken to   |   |
|                      |                      | minimise, as far as  |   |
|                      |                      | technically and      |   |
|                      |                      | practically          |   |
|                      |                      | possible, exposure   |   |
|                      |                      | and emissions with a |   |
|                      |                      | view to minimising   |   |
|                      |                      | the likelihood of    |   |
|                      |                      | adverse effects.     |   |
|                      |                      | Measures to ensure   |   |
|                      |                      | adequate control     |   |
|                      |                      | should be identified |   |
|                      |                      | in any Chemical      |   |
|                      |                      | Safety Report. These |   |
|                      |                      | measures should be   |   |
|                      |                      | applied and, where   |   |
|                      |                      | appropriate,         |   |
|                      |                      | recommended to other |   |
|                      |                      | actors down the      |   |
|                      |                      | supply chain.***     |   |
+----------------------+----------------------+----------------------+---+
| ***(64)              | Amendment 20         | ***It was agreed     |   |
| Methodologies to     |                      | that recital 64 be   |   |
| establish thresholds | RECITAL 64           | modified as          |   |
| for carcinogenic and |                      | follows:***          |   |
| mutagenic substances | ***deleted***        |                      |   |
| may be developed     |                      | ***(64)              |   |
| taking into account  |                      | Methodologies to     |   |
| the outcomes of      |                      | establish thresholds |   |
| RIPs. The relevant   |                      | for carcinogenic and |   |
| Annex may be amended |                      | mutagenic substances |   |
| on the basis of      |                      | may be developed     |   |
| these methodologies  |                      | taking into account  |   |
| to allow thresholds  |                      | the outcomes of      |   |
| where appropriate to |                      | RIPs. The relevant   |   |
| be used in the       |                      | Annex may be amended |   |
| context of           |                      | on the basis of      |   |
| authorising the use  |                      | these methodologies  |   |
| of carcinogenic and  |                      | to allow thresholds  |   |
| mutagenic            |                      | where appropriate to |   |
| substances.***       |                      | be used, while       |   |
|                      |                      | ensuring high level  |   |
|                      |                      | of protection of     |   |
|                      |                      | human health and the |   |
|                      |                      | environment. ~~in    |   |
|                      |                      | the context of       |   |
|                      |                      | authorising the use  |   |
|                      |                      | of carcinogenic and  |   |
|                      |                      | mutagenic            |   |
|                      |                      | substances~~.***     |   |
+----------------------+----------------------+----------------------+---+

+----------------------+----------------------+----------------------+---+
| Article 54           | Amendment 73         | It was agreed that   |   |
|                      |                      | Article 54 should be |   |
| Article 54\          | The aim of this      | modified as follows: |   |
| Aim of authorisation | Title is to ensure   |                      |   |
|                      | ***that substances   | Article 54\          |   |
| The aim of this      | of very high concern | Aim of authorisation |   |
| Title is to ensure   | are replaced by      | **and considerations |   |
| ***the good          | safer alternative    | for substitution**   |   |
| functioning of the   | substances or        |                      |   |
| internal market      | technologies, where  | The aim of this      |   |
| while assuring that  | available. Where no  | Title is to ensure   |   |
| the risks from       | such alternatives    | the good functioning |   |
| substances of very   | are available, and   | of the internal      |   |
| high concern are     | where the benefits   | market while         |   |
| properly controlled  | to society outweigh  | assuring that the    |   |
| and that these       | the risks connected  | risks from           |   |
| substances are       | with the use of such | substances of very   |   |
| eventually replaced  | substances, the aim  | high concern are     |   |
| by suitable          | of this Title is to  | properly controlled  |   |
| alternative          | ensure that the use  | and that these       |   |
| substances or        | of substances of     | substances are       |   |
| technologies where   | very high concern is | ***progressively***  |   |
| these are            | properly controlled  | replaced by suitable |   |
| economically and     | and that             | alternative          |   |
| technically          | alternatives are     | substances or        |   |
| viable.***           | encouraged. Its      | technologies where   |   |
|                      | provisions are       | these are            |   |
|                      | underpinned by the   | economically and     |   |
|                      | precautionary        | technically viable.  |   |
|                      | principle.***        | ***To this end all   |   |
|                      |                      | manufacturers,       |   |
|                      |                      | importers and        |   |
|                      |                      | downstream users     |   |
|                      |                      | applying for         |   |
|                      |                      | authorisations shall |   |
|                      |                      | analyse the          |   |
|                      |                      | availability of      |   |
|                      |                      | alternatives,        |   |
|                      |                      | consider their       |   |
|                      |                      | risks, and the       |   |
|                      |                      | technical and        |   |
|                      |                      | economic feasibility |   |
|                      |                      | of substitution.***  |   |
+----------------------+----------------------+----------------------+---+
| Article 56 f         | Amendment 78         | It was agreed that   |   |
|                      |                      | the wording of       |   |
| \(f\) substances -   | \(f\) substances -   | Article 56(f) in the |   |
| such as those having | such as those having | Common Position      |   |
| endocrine disrupting | endocrine disrupting | should be retained   |   |
| properties or those  | properties or those  | and that paragraph   |   |
| having persistent,   | having persistent,   | 4a be introduced in  |   |
| bioaccumulative and  | bioaccumulative and  | Article 137:         |   |
| toxic properties or  | toxic properties or  |                      |   |
| very persistent and  | very persistent and  | ***\_\_\_\_***       |   |
| very bioaccumulative | very bioaccumulative |                      |   |
| properties, which do | properties, which do | ***Art 137***        |   |
| not fulfil the       | not fulfil the       |                      |   |
| criteria of points   | criteria of points   | ***4 a The           |   |
| (d) or (e) - ***for  | (d) or (e) - which   | Commission shall     |   |
| which there is       | are identified       | carry out a review   |   |
| scientific evidence  | ***as*** ***giving   | of Annex XIII by 18  |   |
| of probable serious  | rise to a similar    | months after entry   |   |
| effects to human     | level of concern     | into force of this   |   |
| health or the        | as*** ***substances  | Regulation, to       |   |
| environment which    | listed in points (a) | assess the adequacy  |   |
| give rise to an      | to (e)*** on a       | of the criteria for  |   |
| equivalent level of  | case-by-case basis   | the identification   |   |
| concern to those of  | in accordance with   | substances which are |   |
| other substances     | the procedure set    | persistent,          |   |
| listed in points (a) | out in Article 58.   | bioaccumulative and  |   |
| to (e) and*** which  |                      | toxic or very        |   |
| are identified on a  |                      | persistent and very  |   |
| case-by-case basis   |                      | bioaccumulative,     |   |
| in accordance with   |                      | with a view to       |   |
| the procedure set    |                      | proposing an         |   |
| out in Article 58.   |                      | amendment to it, if  |   |
|                      |                      | appropriate, in      |   |
| \(66\) Experience at |                      | accordance with the  |   |
| international level  |                      | procedure referred   |   |
| shows that           |                      | to in Article        |   |
| substances with      |                      | 132(3a).***          |   |
| characteristics      |                      |                      |   |
| rendering them       |                      | ***\_\_\_\_\_\_***   |   |
| persistent, liable   |                      |                      |   |
| to bioaccumulate and |                      | In addition, it was  |   |
| toxic, or very       |                      | agreed that recital  |   |
| persistent and very  |                      | 66 should be         |   |
| liable to            |                      | modified as follows: |   |
| bioaccumulate,       |                      |                      |   |
| present a very high  |                      | \(66\) Experience at |   |
| concern, while       |                      | international level  |   |
| criteria have been   |                      | shows that           |   |
| developed allowing   |                      | substances with      |   |
| the identification   |                      | characteristics      |   |
| of such substances.  |                      | rendering them       |   |
| For certain other    |                      | persistent, liable   |   |
| substances concerns  |                      | to bioaccumulate and |   |
| are sufficiently     |                      | toxic, or very       |   |
| high to address them |                      | persistent and very  |   |
| in the same way on a |                      | liable to            |   |
| case by case basis.  |                      | bioaccumulate,       |   |
|                      |                      | present a very high  |   |
|                      |                      | concern, while       |   |
|                      |                      | criteria have been   |   |
|                      |                      | developed allowing   |   |
|                      |                      | the identification   |   |
|                      |                      | of such substances.  |   |
|                      |                      | For certain other    |   |
|                      |                      | substances concerns  |   |
|                      |                      | are sufficiently     |   |
|                      |                      | high to address them |   |
|                      |                      | in the same way on a |   |
|                      |                      | case by case basis.  |   |
|                      |                      | ***The criteria in   |   |
|                      |                      | Annex XIII should be |   |
|                      |                      | reviewed taking into |   |
|                      |                      | account the current  |   |
|                      |                      | and any new          |   |
|                      |                      | experience in the    |   |
|                      |                      | identification of    |   |
|                      |                      | the above mentioned  |   |
|                      |                      | substances, and if   |   |
|                      |                      | appropriate, be      |   |
|                      |                      | amended with a view  |   |
|                      |                      | to ensuring a high   |   |
|                      |                      | level of protection  |   |
|                      |                      | for human health and |   |
|                      |                      | the environment.***  |   |
+----------------------+----------------------+----------------------+---+
| Article 56 fb        | Amendment 80         | It was agreed that   |   |
|                      |                      | the wording in the   |   |
| Does not exist.      | ***(fb) substances   | Common Position      |   |
|                      | which are            | should be retained.  |   |
|                      | ingredients added to | The Commission       |   |
|                      | tobacco products     | Statement in Annex C |   |
|                      | within the meaning   | responds to the      |   |
|                      | of Article 2(1) and  | concern clarifying   |   |
|                      | (5) of Directive     | that specific        |   |
|                      | 2001/37/EC on the    | effects of tobacco   |   |
|                      | approximation of the | additives will be    |   |
|                      | laws, regulations    | addressed in the     |   |
|                      | and administrative   | context of a         |   |
|                      | provisions of the    | forthcoming review   |   |
|                      | Member States        | of the Tobacco       |   |
|                      | concerning the       | Products Directive.  |   |
|                      | manufacture,         |                      |   |
|                      | presentation and     |                      |   |
|                      | sale of tobacco      |                      |   |
|                      | products.***         |                      |   |
+----------------------+----------------------+----------------------+---+

+----------------------+----------------------+----------------------+---+
| Article 57.2 a       | Amendment 85         | It was agreed that   |   |
|                      |                      | the wording in the   |   |
| Does not exist.      | ***2a. Such          | Common Position      |   |
|                      | exemptions shall not | should be retained.  |   |
|                      | be granted to uses   | The Commission       |   |
|                      | or categories of     | Statement in Annex C |   |
|                      | uses for substances  | responds to the      |   |
|                      | referred to in       | concern clarifying   |   |
|                      | Article 56 which are | that specific        |   |
|                      | ingredients added to | effects of tobacco   |   |
|                      | tobacco products     | additives will be    |   |
|                      | within the meaning   | addressed in the     |   |
|                      | of Article 2(1) and  | context of a         |   |
|                      | (5) of Directive     | forthcoming review   |   |
|                      | 2001/37/EC on the    | of the Tobacco       |   |
|                      | approximation of the | Products Directive.  |   |
|                      | laws, regulations    |                      |   |
|                      | and administrative   |                      |   |
|                      | provisions of the    |                      |   |
|                      | Member States        |                      |   |
|                      | concerning the       |                      |   |
|                      | manufacture,         |                      |   |
|                      | presentation and     |                      |   |
|                      | sale of tobacco      |                      |   |
|                      | products,            |                      |   |
|                      | notwithstanding      |                      |   |
|                      | Article 12 of that   |                      |   |
|                      | Directive.***        |                      |   |
+----------------------+----------------------+----------------------+---+
| Article 57.3 ca      | Amendment 89         | It was agreed that   |   |
|                      |                      | the wording in the   |   |
| Does not exist.      | ***(ca) substances   | Common Position      |   |
|                      | which are            | should be retained.  |   |
|                      | ingredients added to | The Commission       |   |
|                      | tobacco products     | Statement in Annex C |   |
|                      | within the meaning   | responses to the     |   |
|                      | of Article 2(1) and  | concern clarifying   |   |
|                      | (5) of Directive     | that specific        |   |
|                      | 2001/37 on the       | effects of tobacco   |   |
|                      | approximation of the | additives will be    |   |
|                      | laws, regulations    | addressed in the     |   |
|                      | and administrative   | context of a         |   |
|                      | provisions of the    | forthcoming review   |   |
|                      | Member States        | of the Tobacco       |   |
|                      | concerning the       | Products Directive.  |   |
|                      | manufacture,         |                      |   |
|                      | presentation and     |                      |   |
|                      | sale of tobacco      |                      |   |
|                      | products.***         |                      |   |
+----------------------+----------------------+----------------------+---+
| Article 57.6         | Does not exist       | It was agreed, in    |   |
|                      |                      | response to various  |   |
| 6\. A substance      |                      | amendments voted by  |   |
| listed in Annex XIV  |                      | the European         |   |
| may be subjected to  |                      | Parliament that      |   |
| new restrictions     |                      | Article 57(6) should |   |
| under the procedure  |                      | be modified as       |   |
| outlined in Title    |                      | follows:             |   |
| VIII covering the    |                      |                      |   |
| risks to human       |                      | 6\. A substance      |   |
| health or the        |                      | listed in Annex XIV  |   |
| environment from the |                      | may be subjected to  |   |
| use of the substance |                      | new restrictions     |   |
| in article(s).       |                      | under the procedure  |   |
|                      |                      | outlined in Title    |   |
|                      |                      | VIII covering the    |   |
|                      |                      | risks to human       |   |
|                      |                      | health or the        |   |
|                      |                      | environment from the |   |
|                      |                      | ***presence*** of    |   |
|                      |                      | the substance in     |   |
|                      |                      | ***(an)***           |   |
|                      |                      | article(s).          |   |
+----------------------+----------------------+----------------------+---+

+----------------------+---+----------------------+---+----------------------+---+
| Article 59.2         |   | Amendment 99         | I |                      |   |
|                      |   |                      | t |                      |   |
| 2\. ***Without       |   | 2\. An authorisation | w |                      |   |
| prejudice to         |   | shall be granted     | a |                      |   |
| paragraph 3,*** an   |   | ***only*** if***:*** | s |                      |   |
| authorisation shall  |   |                      | a |                      |   |
| be granted if        |   | ***(a)***            | g |                      |   |
|                      |   | ***suitable          | r |                      |   |
| the risk to human    |   | alternative          | e |                      |   |
| health or the        |   | substances or        | e |                      |   |
| environment from the |   | technologies do not  | d |                      |   |
| use of a substance   |   | exist, and measures  | t |                      |   |
| arising from the     |   | are in place to      | h |                      |   |
| intrinsic properties |   | minimise exposure,   | a |                      |   |
| specified in         |   | and***               | t |                      |   |
| ***Annex XIV*** is   |   |                      | A |                      |   |
| adequately           |   | ***(b)*** ***it is   | r |                      |   |
| controlled in        |   | demonstrated that    | t |                      |   |
| accordance with      |   | the social and       | i |                      |   |
| section 6.4 of Annex |   | economic advantages  | c |                      |   |
| I and as documented  |   | outweigh the risks   | l |                      |   |
| in the applicant's   |   | to human health or   | e |                      |   |
| chemical safety      |   | the environment      | 5 |                      |   |
| report. The          |   | which arise from the | 9 |                      |   |
| Commission shall     |   | use of the           | ( |                      |   |
| take into account    |   | substance, and***    | 2 |                      |   |
| all discharges,      |   |                      | ) |                      |   |
| emissions and losses |   | ***(c***) the risk   | s |                      |   |
| known at the time of |   | to human health or   | h |                      |   |
| decision.            |   | the environment from | o |                      |   |
|                      |   | the use of a         | u |                      |   |
| ***The Commission    |   | substance arising    | l |                      |   |
| shall not consider   |   | from the intrinsic   | d |                      |   |
| the risks to human   |   | properties specified | b |                      |   |
| health arising from  |   | in ***Annex          | e |                      |   |
| the use of a         |   | XIV(a)*** is         | m |                      |   |
| substance in a       |   | adequately           | o |                      |   |
| medical device       |   | controlled in        | d |                      |   |
| regulated by Council |   | accordance with      | i |                      |   |
| Directive 90/385/EEC |   | section 6.4 of Annex | f |                      |   |
| of 20 June 1990 on   |   | I and as documented  | i |                      |   |
| the approximation of |   | in the applicant's   | e |                      |   |
| the laws of the      |   | chemical safety      | d |                      |   |
| Member States        |   | report. The          | a |                      |   |
| relating to active   |   | Commission shall     | s |                      |   |
| implantable medical  |   | take into account    | f |                      |   |
| devices, Council     |   | all discharges,      | o |                      |   |
| Directive 93/42/EEC  |   | emissions and losses | l |                      |   |
| of 14 June 1993      |   | known at the time of | l |                      |   |
| concerning medical   |   | decision.            | o |                      |   |
| devices or           |   |                      | w |                      |   |
| Directive 98/79/EC   |   |                      | s |                      |   |
| of the European      |   |                      | : |                      |   |
| Parliament and of    |   |                      |   |                      |   |
| the Council of       |   |                      | 2 |                      |   |
| 27 October 1998 on   |   |                      | \ |                      |   |
| in vitro diagnostic  |   |                      | . |                      |   |
| medical devices.***  |   |                      | W |                      |   |
|                      |   |                      | i |                      |   |
|                      |   |                      | t |                      |   |
|                      |   |                      | h |                      |   |
|                      |   |                      | o |                      |   |
|                      |   |                      | u |                      |   |
|                      |   |                      | t |                      |   |
|                      |   |                      | p |                      |   |
|                      |   |                      | r |                      |   |
|                      |   |                      | e |                      |   |
|                      |   |                      | j |                      |   |
|                      |   |                      | u |                      |   |
|                      |   |                      | d |                      |   |
|                      |   |                      | i |                      |   |
|                      |   |                      | c |                      |   |
|                      |   |                      | e |                      |   |
|                      |   |                      | t |                      |   |
|                      |   |                      | o |                      |   |
|                      |   |                      | p |                      |   |
|                      |   |                      | a |                      |   |
|                      |   |                      | r |                      |   |
|                      |   |                      | a |                      |   |
|                      |   |                      | g |                      |   |
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|                      |   |                      | 2 |                      |   |
|                      |   |                      | / |                      |   |
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|                      |   |                      | 3 |                      |   |
|                      |   |                      | . |                      |   |
+----------------------+---+----------------------+---+----------------------+---+
| Article 59.3         |   | Amendment 100        | I |                      |   |
|                      |   |                      | t |                      |   |
| ***3. Paragraph 2    |   | ***deleted***        | w |                      |   |
| shall not apply      |   |                      | a |                      |   |
| to:***               |   |                      | s |                      |   |
|                      |   |                      | a |                      |   |
| ***(a) substances    |   |                      | g |                      |   |
| meeting the criteria |   |                      | r |                      |   |
| in Article 56 (a),   |   |                      | e |                      |   |
| (b), (c) and (f) for |   |                      | e |                      |   |
| which it is not      |   |                      | d |                      |   |
| possible to          |   |                      | t |                      |   |
| determine a          |   |                      | h |                      |   |
| threshold in         |   |                      | a |                      |   |
| accordance with      |   |                      | t |                      |   |
| section 6.4 of Annex |   |                      | A |                      |   |
| I;***                |   |                      | r |                      |   |
|                      |   |                      | t |                      |   |
| ***(b) substances    |   |                      | i |                      |   |
| meeting the criteria |   |                      | c |                      |   |
| in Article 56 (d)    |   |                      | l |                      |   |
| and (e).***          |   |                      | e |                      |   |
|                      |   |                      | 5 |                      |   |
|                      |   |                      | 9 |                      |   |
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|                      |   |                      | 3 |                      |   |
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|                      |   |                      | } |                      |   |
+----------------------+---+----------------------+---+----------------------+---+
| Article 59.4         | A |                      | I |                      |   |
| introductory part    | m |                      | t |                      |   |
|                      | e |                      | w |                      |   |
| 4\. ***If an         | n |                      | a |                      |   |
| authorisation cannot | d |                      | s |                      |   |
| be granted under     | m |                      | a |                      |   |
| paragraph 2 or for   | e |                      | g |                      |   |
| substances listed in | n |                      | r |                      |   |
| paragraph 3, an      | t |                      | e |                      |   |
| authorisation may be | 1 |                      | e |                      |   |
| granted if it is     | 0 |                      | d |                      |   |
| shown that           | 1 |                      | t |                      |   |
| socio-economic       |   |                      | h |                      |   |
| benefits outweigh    | 4 |                      | a |                      |   |
| the risk to human    | \ |                      | t |                      |   |
| health or the        | . |                      | A |                      |   |
| environment arising  | * |                      | r |                      |   |
| from the use of the  | * |                      | t |                      |   |
| substance and if     | * |                      | i |                      |   |
| there are no         | T |                      | c |                      |   |
| suitable alternative | h |                      | l |                      |   |
| substances or        | e |                      | e |                      |   |
| technologies.        | * |                      | 5 |                      |   |
| This*** decision     | * |                      | 9 |                      |   |
| shall be taken after | * |                      | ( |                      |   |
| consideration of all | d |                      | 4 |                      |   |
| of the following     | e |                      | ) |                      |   |
| elements:            | c |                      | b |                      |   |
|                      | i |                      | e |                      |   |
| \(a\) the risk posed | s |                      | m |                      |   |
| by the uses of the   | i |                      | o |                      |   |
| substance;           | o |                      | d |                      |   |
|                      | n |                      | i |                      |   |
| \(b\) the            | * |                      | f |                      |   |
| socio-economic       | * |                      | i |                      |   |
| benefits arising     | * |                      | e |                      |   |
| from its use and the | t |                      | d |                      |   |
| socio-economic       | o |                      | a |                      |   |
| implications of a    | g |                      | s |                      |   |
| refusal to authorise | r |                      | f |                      |   |
| as demonstrated by   | a |                      | o |                      |   |
| the applicant or     | n |                      | l |                      |   |
| other interested     | t |                      | l |                      |   |
| parties;             | a |                      | o |                      |   |
|                      | u |                      | w |                      |   |
| \(c\) the analysis   | t |                      | s |                      |   |
| of the alternatives  | h |                      | : |                      |   |
| submitted by the     | o |                      |   |                      |   |
| applicant under      | r |                      | 4 |                      |   |
| Article 61(4)(e) and | i |                      | \ |                      |   |
| any third party      | s |                      | . |                      |   |
| contributions        | a |                      | I |                      |   |
| submitted under      | t |                      | f |                      |   |
| Article 63(2);       | i |                      | a |                      |   |
|                      | o |                      | n |                      |   |
| \(d\) available      | n |                      | a |                      |   |
| information on the   | p |                      | u |                      |   |
| risks to human       | u |                      | t |                      |   |
| health or the        | r |                      | h |                      |   |
| environment of any   | s |                      | o |                      |   |
| alternative          | u |                      | r |                      |   |
| substances or        | a |                      | i |                      |   |
| technologies.        | n |                      | s |                      |   |
|                      | t |                      | a |                      |   |
|                      | t |                      | t |                      |   |
|                      | o |                      | i |                      |   |
|                      | p |                      | o |                      |   |
|                      | a |                      | n |                      |   |
|                      | r |                      | c |                      |   |
|                      | a |                      | a |                      |   |
|                      | g |                      | n |                      |   |
|                      | r |                      | n |                      |   |
|                      | a |                      | o |                      |   |
|                      | p |                      | t |                      |   |
|                      | h |                      | b |                      |   |
|                      | 2 |                      | e |                      |   |
|                      | * |                      | g |                      |   |
|                      | * |                      | r |                      |   |
|                      | * |                      | a |                      |   |
|                      | s |                      | n |                      |   |
|                      | h |                      | t |                      |   |
|                      | a |                      | e |                      |   |
|                      | l |                      | d |                      |   |
|                      | l |                      | u |                      |   |
|                      | b |                      | n |                      |   |
|                      | e |                      | d |                      |   |
|                      | t |                      | e |                      |   |
|                      | a |                      | r |                      |   |
|                      | k |                      | p |                      |   |
|                      | e |                      | a |                      |   |
|                      | n |                      | r |                      |   |
|                      | a |                      | a |                      |   |
|                      | f |                      | g |                      |   |
|                      | t |                      | r |                      |   |
|                      | e |                      | a |                      |   |
|                      | r |                      | p |                      |   |
|                      | c |                      | h |                      |   |
|                      | o |                      |   |                      |   |
|                      | n |                      | 2 |                      |   |
|                      | s |                      | o |                      |   |
|                      | i |                      | r |                      |   |
|                      | d |                      | f |                      |   |
|                      | e |                      | o |                      |   |
|                      | r |                      | r |                      |   |
|                      | a |                      | s |                      |   |
|                      | t |                      | u |                      |   |
|                      | i |                      | b |                      |   |
|                      | o |                      | s |                      |   |
|                      | n |                      | t |                      |   |
|                      | o |                      | a |                      |   |
|                      | f |                      | n |                      |   |
|                      | a |                      | c |                      |   |
|                      | l |                      | e |                      |   |
|                      | l |                      | s |                      |   |
|                      | o |                      | l |                      |   |
|                      | f |                      | i |                      |   |
|                      | t |                      | s |                      |   |
|                      | h |                      | t |                      |   |
|                      | e |                      | e |                      |   |
|                      | f |                      | d |                      |   |
|                      | o |                      | i |                      |   |
|                      | l |                      | n |                      |   |
|                      | l |                      | p |                      |   |
|                      | o |                      | a |                      |   |
|                      | w |                      | r |                      |   |
|                      | i |                      | a |                      |   |
|                      | n |                      | g |                      |   |
|                      | g |                      | r |                      |   |
|                      | e |                      | a |                      |   |
|                      | l |                      | p |                      |   |
|                      | e |                      | h |                      |   |
|                      | m |                      |   |                      |   |
|                      | e |                      | 3 |                      |   |
|                      | n |                      | , |                      |   |
|                      | t |                      | a |                      |   |
|                      | s |                      | n |                      |   |
|                      | : |                      | a |                      |   |
|                      |   |                      | u |                      |   |
|                      |   |                      | t |                      |   |
|                      |   |                      | h |                      |   |
|                      |   |                      | o |                      |   |
|                      |   |                      | r |                      |   |
|                      |   |                      | i |                      |   |
|                      |   |                      | s |                      |   |
|                      |   |                      | a |                      |   |
|                      |   |                      | t |                      |   |
|                      |   |                      | i |                      |   |
|                      |   |                      | o |                      |   |
|                      |   |                      | n |                      |   |
|                      |   |                      | m |                      |   |
|                      |   |                      | a |                      |   |
|                      |   |                      | y |                      |   |
|                      |   |                      | * |                      |   |
|                      |   |                      | * |                      |   |
|                      |   |                      | * |                      |   |
|                      |   |                      | o |                      |   |
|                      |   |                      | n |                      |   |
|                      |   |                      | l |                      |   |
|                      |   |                      | y |                      |   |
|                      |   |                      | * |                      |   |
|                      |   |                      | * |                      |   |
|                      |   |                      | * |                      |   |
|                      |   |                      | b |                      |   |
|                      |   |                      | e |                      |   |
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|                      |   |                      | r |                      |   |
|                      |   |                      | a |                      |   |
|                      |   |                      | n |                      |   |
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|                      |   |                      | e |                      |   |
|                      |   |                      | d |                      |   |
|                      |   |                      | i |                      |   |
|                      |   |                      | f |                      |   |
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|                      |   |                      | t |                      |   |
|                      |   |                      | i |                      |   |
|                      |   |                      | s |                      |   |
|                      |   |                      | s |                      |   |
|                      |   |                      | h |                      |   |
|                      |   |                      | o |                      |   |
|                      |   |                      | w |                      |   |
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|                      |   |                      | t |                      |   |
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|                      |   |                      | a |                      |   |
|                      |   |                      | t |                      |   |
|                      |   |                      | s |                      |   |
|                      |   |                      | o |                      |   |
|                      |   |                      | c |                      |   |
|                      |   |                      | i |                      |   |
|                      |   |                      | o |                      |   |
|                      |   |                      | - |                      |   |
|                      |   |                      | e |                      |   |
|                      |   |                      | c |                      |   |
|                      |   |                      | o |                      |   |
|                      |   |                      | n |                      |   |
|                      |   |                      | o |                      |   |
|                      |   |                      | m |                      |   |
|                      |   |                      | i |                      |   |
|                      |   |                      | c |                      |   |
|                      |   |                      | b |                      |   |
|                      |   |                      | e |                      |   |
|                      |   |                      | n |                      |   |
|                      |   |                      | e |                      |   |
|                      |   |                      | f |                      |   |
|                      |   |                      | i |                      |   |
|                      |   |                      | t |                      |   |
|                      |   |                      | s |                      |   |
|                      |   |                      | o |                      |   |
|                      |   |                      | u |                      |   |
|                      |   |                      | t |                      |   |
|                      |   |                      | w |                      |   |
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|                      |   |                      | h |                      |   |
|                      |   |                      | t |                      |   |
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|                      |   |                      | e |                      |   |
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|                      |   |                      | s |                      |   |
|                      |   |                      | k |                      |   |
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|                      |   |                      | h |                      |   |
|                      |   |                      | u |                      |   |
|                      |   |                      | m |                      |   |
|                      |   |                      | a |                      |   |
|                      |   |                      | n |                      |   |
|                      |   |                      | h |                      |   |
|                      |   |                      | e |                      |   |
|                      |   |                      | a |                      |   |
|                      |   |                      | l |                      |   |
|                      |   |                      | t |                      |   |
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|                      |   |                      | t |                      |   |
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|                      |   |                      | s |                      |   |
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|                      |   |                      | n |                      |   |
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|                      |   |                      | f |                      |   |
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|                      |   |                      | m |                      |   |
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|                      |   |                      | u |                      |   |
|                      |   |                      | s |                      |   |
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|                      |   |                      | f |                      |   |
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|                      |   |                      | s |                      |   |
|                      |   |                      | u |                      |   |
|                      |   |                      | b |                      |   |
|                      |   |                      | s |                      |   |
|                      |   |                      | t |                      |   |
|                      |   |                      | a |                      |   |
|                      |   |                      | n |                      |   |
|                      |   |                      | c |                      |   |
|                      |   |                      | e |                      |   |
|                      |   |                      | a |                      |   |
|                      |   |                      | n |                      |   |
|                      |   |                      | d |                      |   |
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|                      |   |                      | f |                      |   |
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|                      |   |                      | r |                      |   |
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|                      |   |                      | a |                      |   |
|                      |   |                      | r |                      |   |
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|                      |   |                      | n |                      |   |
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|                      |   |                      | s |                      |   |
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|                      |   |                      | a |                      |   |
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|                      |   |                      | n |                      |   |
|                      |   |                      | a |                      |   |
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|                      |   |                      | . |                      |   |
|                      |   |                      | T |                      |   |
|                      |   |                      | h |                      |   |
|                      |   |                      | i |                      |   |
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|                      |   |                      | d |                      |   |
|                      |   |                      | e |                      |   |
|                      |   |                      | c |                      |   |
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|                      |   |                      | s |                      |   |
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|                      |   |                      | o |                      |   |
|                      |   |                      | n |                      |   |
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|                      |   |                      | h |                      |   |
|                      |   |                      | a |                      |   |
|                      |   |                      | l |                      |   |
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|                      |   |                      | t |                      |   |
|                      |   |                      | a |                      |   |
|                      |   |                      | k |                      |   |
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|                      |   |                      | n |                      |   |
|                      |   |                      | a |                      |   |
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|                      |   |                      | r |                      |   |
|                      |   |                      | c |                      |   |
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|                      |   |                      | n |                      |   |
|                      |   |                      | s |                      |   |
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|                      |   |                      | a |                      |   |
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|                      |   |                      | n |                      |   |
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|                      |   |                      | a |                      |   |
|                      |   |                      | l |                      |   |
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|                      |   |                      | o |                      |   |
|                      |   |                      | w |                      |   |
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|                      |   |                      | n |                      |   |
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|                      |   |                      | l |                      |   |
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|                      |   |                      | m |                      |   |
|                      |   |                      | e |                      |   |
|                      |   |                      | n |                      |   |
|                      |   |                      | t |                      |   |
|                      |   |                      | s |                      |   |
|                      |   |                      | * |                      |   |
|                      |   |                      | * |                      |   |
|                      |   |                      | * |                      |   |
|                      |   |                      | a |                      |   |
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+----------------------+---+----------------------+---+----------------------+---+
| Article 59.7         |   | Amendment 102        |   | It was agreed that   |   |
|                      |   |                      |   | paragraph 7 will be  |   |
| 7\. ***Where an      |   | 7\. ***The duration  |   | deleted as a         |   |
| application for      |   | of the time-limited  |   | consequence of the   |   |
| authorisation        |   | authorisation will   |   | modification of      |   |
| includes the         |   | be determined on the |   | paragraph 8:         |   |
| information          |   | basis of the         |   |                      |   |
| specified in Article |   | information          |   | ~~7. ***Where an     |   |
| 61(5)(b), this       |   | specified in Article |   | application for      |   |
| information shall be |   | 61(4)(eb) and taking |   | authorisation        |   |
| considered in        |   | into account other   |   | includes the         |   |
| determining the      |   | available            |   | information          |   |
| duration of the      |   | information.***      |   | specified in Article |   |
| time-limited review  |   |                      |   | 61(5)(b), this       |   |
| period in paragraph  |   |                      |   | information shall be |   |
| 8 of this            |   |                      |   | considered in        |   |
| Article.***          |   |                      |   | determining the      |   |
|                      |   |                      |   | duration of the      |   |
|                      |   |                      |   | time-limited review  |   |
|                      |   |                      |   | period in paragraph  |   |
|                      |   |                      |   | 8 of this            |   |
|                      |   |                      |   | Article.***~~        |   |
+----------------------+---+----------------------+---+----------------------+---+
| Article 59.8         |   | Amendment 103        |   | It was agreed that   |   |
|                      |   |                      |   | Article 59(8) be     |   |
| 8\. Authorisations   |   | 8\. Authorisations   |   | modified as follows: |   |
| shall be subject to  |   | shall be subject to  |   |                      |   |
| ***a time-limited*** |   | review ***periods    |   | 8\. Authorisations   |   |
| review ***(whose     |   | and*** ***to the     |   | shall be subject to  |   |
| duration shall be    |   | presentation of      |   | a time-limited       |   |
| determined on a      |   | substitution plans,  |   | review ~~(whose      |   |
| case-by-case basis)  |   | and may*** be        |   | duration shall be    |   |
| without prejudice to |   | subject to           |   | determined on a      |   |
| any decision on a    |   | ***other***          |   | case-by-case         |   |
| future review period |   | conditions,          |   | basis)~~ without     |   |
| and shall            |   | including            |   | prejudice to any     |   |
| normally*** be       |   | monitoring.          |   | decision on a future |   |
| subject to           |   | ***Authorisations    |   | review period and    |   |
| conditions,          |   | shall be subject to  |   | shall normally be    |   |
| including            |   | a time-limit not     |   | subject to           |   |
| monitoring.          |   | exceeding five       |   | conditions,          |   |
|                      |   | years.***            |   | including            |   |
|                      |   |                      |   | monitoring. ***The   |   |
|                      |   |                      |   | duration of the      |   |
|                      |   |                      |   | time-limited review  |   |
|                      |   |                      |   | for any              |   |
|                      |   |                      |   | authorisation shall  |   |
|                      |   |                      |   | be determined on a   |   |
|                      |   |                      |   | case by case basis   |   |
|                      |   |                      |   | taking into account  |   |
|                      |   |                      |   | all relevant         |   |
|                      |   |                      |   | information          |   |
|                      |   |                      |   | including the        |   |
|                      |   |                      |   | elements listed in   |   |
|                      |   |                      |   | paragraphs 4(a) to   |   |
|                      |   |                      |   | (d), as appropriate. |   |
|                      |   |                      |   | ~~all relevant       |   |
|                      |   |                      |   | information,         |   |
|                      |   |                      |   | including the        |   |
|                      |   |                      |   | analysis of          |   |
|                      |   |                      |   | alternatives under   |   |
|                      |   |                      |   | Article 61.4(e) and  |   |
|                      |   |                      |   | any substitution     |   |
|                      |   |                      |   | plan provided under  |   |
|                      |   |                      |   | Article 61.4(ea) or  |   |
|                      |   |                      |   | 61.5(b).~~***        |   |
+----------------------+---+----------------------+---+----------------------+---+
| Article 60.1 subpara | A |                      | I |                      |   |
| 1-3                  | m |                      | t |                      |   |
|                      | e |                      | w |                      |   |
| 1\. Authorisations   | n |                      | a |                      |   |
| ***granted in        | d |                      | s |                      |   |
| accordance with      | m |                      | a |                      |   |
| Article 59*** shall  | e |                      | g |                      |   |
| be regarded as valid | n |                      | r |                      |   |
| until the Commission | t |                      | e |                      |   |
| decides ***to amend  | 1 |                      | e |                      |   |
| or withdraw the      | 0 |                      | d |                      |   |
| authorisation in the | 5 |                      | t |                      |   |
| context of a         |   |                      | h |                      |   |
| review***, provided  | 1 |                      | a |                      |   |
| that the holder of   | \ |                      | t |                      |   |
| the authorisation    | . |                      | A |                      |   |
| submits a ***review  | A |                      | r |                      |   |
| report*** at least   | u |                      | t |                      |   |
| 18 months before the | t |                      | i |                      |   |
| expiry of the        | h |                      | c |                      |   |
| time-limit***ed      | o |                      | l |                      |   |
| review period***.    | r |                      | e |                      |   |
| Rather than          | i |                      | 6 |                      |   |
| re-submitting all    | s |                      | 0 |                      |   |
| elements of the      | a |                      | b |                      |   |
| original application | t |                      | e |                      |   |
| for the current      | i |                      | m |                      |   |
| authorisation, the   | o |                      | o |                      |   |
| ***holder of an      | n |                      | d |                      |   |
| authorisation*** may | s |                      | i |                      |   |
| submit only the      | s |                      | f |                      |   |
| number of the        | h |                      | i |                      |   |
| current              | a |                      | e |                      |   |
| authorisation,       | l |                      | d |                      |   |
| ***subject to the    | l |                      | a |                      |   |
| second, third and    | b |                      | s |                      |   |
| fourth               | e |                      | f |                      |   |
| subparagraphs.***    | r |                      | o |                      |   |
|                      | e |                      | l |                      |   |
| ***A holder of an    | g |                      | l |                      |   |
| authorisation        | a |                      | o |                      |   |
| granted in           | r |                      | w |                      |   |
| accordance with      | d |                      | s |                      |   |
| Article 59 shall     | e |                      | : |                      |   |
| submit an update of  | d |                      |   |                      |   |
| any substitution     | a |                      | * |                      |   |
| plan included in his | s |                      | A |                      |   |
| application. If the  | v |                      | r |                      |   |
| holder cannot        | a |                      | t |                      |   |
| demonstrate that the | l |                      | i |                      |   |
| risk is adequately   | i |                      | c |                      |   |
| controlled, he shall | d |                      | l |                      |   |
| submit*** an update  | u |                      | e |                      |   |
| of the               | n |                      | 6 |                      |   |
| socio-economic       | t |                      | 0 |                      |   |
| analysis, analysis   | i |                      | * |                      |   |
| of alternatives and  | l |                      |   |                      |   |
| substitution plan    | t |                      | * |                      |   |
| contained in the     | h |                      | R |                      |   |
| original             | e |                      | e |                      |   |
| application***.***   | C |                      | v |                      |   |
|                      | o |                      | i |                      |   |
| ***If he can now     | m |                      | e |                      |   |
| demonstrate that the | m |                      | w |                      |   |
| risk is adequately   | i |                      | o |                      |   |
| controlled, he shall | s |                      | f |                      |   |
| submit*** an update  | s |                      | A |                      |   |
| of the chemical      | i |                      | u |                      |   |
| safety report.       | o |                      | t |                      |   |
|                      | n |                      | h |                      |   |
| If any other         | d |                      | o |                      |   |
| elements of the      | e |                      | r |                      |   |
| original application | c |                      | i |                      |   |
| have changed, he     | i |                      | s |                      |   |
| shall also submit    | d |                      | a |                      |   |
| updates of these     | e |                      | t |                      |   |
| element(s).          | s |                      | i |                      |   |
|                      | * |                      | o |                      |   |
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+----------------------+---+----------------------+---+----------------------+---+
| Article 61.4 and     |   | Amendment 110        |   | *It was agreed that  |   |
| 61.5                 |   |                      |   | Article 61 be        |   |
|                      |   | 4\. An application   |   | modified as          |   |
| 4\. An application   |   | for authorisation    |   | follows:*            |   |
| for authorisation    |   | shall include the    |   |                      |   |
| shall include the    |   | following            |   | *Article 61\         |   |
| following            |   | information:         |   | Applications for     |   |
| information:         |   |                      |   | authorisations*      |   |
|                      |   | \(a\) the identity   |   |                      |   |
| \(a\) the identity   |   | of the substance(s), |   | \[1.-3. Unchanged.\] |   |
| of the substance(s), |   | as referred to in    |   |                      |   |
| as referred to in    |   | section 2 of         |   | 4\. An application   |   |
| section 2 of         |   | Annex VI;            |   | for authorisation    |   |
| Annex VI;            |   |                      |   | shall include the    |   |
|                      |   | \(b\) the name and   |   | following            |   |
| \(b\) the name and   |   | contact details of   |   | information:         |   |
| contact details of   |   | the person or        |   |                      |   |
| the person or        |   | persons making the   |   | \(a\) the identity   |   |
| persons making the   |   | application;         |   | of the substance(s), |   |
| application;         |   |                      |   | as referred to in    |   |
|                      |   | \(c\) a request for  |   | section 2 of         |   |
| \(c\) a request for  |   | authorisation,       |   | Annex VI;            |   |
| authorisation,       |   | specifying for which |   |                      |   |
| specifying for which |   | use(s) the           |   | \(b\) the name and   |   |
| use(s) the           |   | authorisation is     |   | contact details of   |   |
| authorisation is     |   | sought and covering  |   | the person or        |   |
| sought and covering  |   | the use of the       |   | persons making the   |   |
| the use of the       |   | substance in         |   | application;         |   |
| substance in         |   | preparations and/or  |   |                      |   |
| preparations and/or  |   | the incorporation of |   | \(c\) a request for  |   |
| the incorporation of |   | the substance in     |   | authorisation,       |   |
| the substance in     |   | articles, where this |   | specifying for which |   |
| articles, where this |   | is relevant;         |   | use(s) the           |   |
| is relevant;         |   |                      |   | authorisation is     |   |
|                      |   | \(d\) unless already |   | sought and covering  |   |
| \(d\) unless already |   | submitted as part of |   | the use of the       |   |
| submitted as part of |   | the registration, a  |   | substance in         |   |
| the registration, a  |   | chemical safety      |   | preparations and/or  |   |
| chemical safety      |   | report in accordance |   | the incorporation of |   |
| report in accordance |   | with Annex I         |   | the substance in     |   |
| with Annex I         |   | covering the risks   |   | articles, where this |   |
| covering the risks   |   | to human health      |   | is relevant;         |   |
| to human health      |   | and/or the           |   |                      |   |
| and/or the           |   | environment from the |   | \(d\) unless already |   |
| environment from the |   | use of the           |   | submitted as part of |   |
| use of the           |   | substance(s) arising |   | the registration, a  |   |
| substance(s) arising |   | from the intrinsic   |   | chemical safety      |   |
| from the intrinsic   |   | properties specified |   | report in accordance |   |
| properties specified |   | in Annex XIV;        |   | with Annex I         |   |
| in Annex XIV;        |   |                      |   | covering the risks   |   |
|                      |   | \(e\) an analysis of |   | to human health      |   |
| \(e\) an analysis of |   | the alternatives     |   | and/or the           |   |
| the alternatives     |   | considering their    |   | environment from the |   |
| considering their    |   | risks and the        |   | use of the           |   |
| risks and the        |   | technical and        |   | substance(s) arising |   |
| technical and        |   | economic feasibility |   | from the intrinsic   |   |
| economic feasibility |   | of substitution.     |   | properties specified |   |
| of substitution.     |   |                      |   | in Annex XIV;        |   |
|                      |   | (ea) a               |   |                      |   |
| 5\. The application  |   | socio-economic       |   | \(e\) an analysis of |   |
| may include:         |   | analysis conducted   |   | the alternatives     |   |
|                      |   | in accordance with   |   | considering their    |   |
| \(a\) a              |   | Annex XVI;           |   | risks and the        |   |
| socio-economic       |   |                      |   | technical and        |   |
| analysis conducted   |   | (eb) a substitution  |   | economic feasibility |   |
| in accordance with   |   | plan, including      |   | of substitution*,    |   |
| Annex XVI;           |   | research and         |   | **and including      |   |
|                      |   | development and a    |   | information about    |   |
| \(b\) where          |   | timetable for        |   | any relevant         |   |
| appropriate a        |   | proposed actions by  |   | research and         |   |
| substitution plan,   |   | the applicant.       |   | development          |   |
| including research   |   |                      |   | activities by the    |   |
| and development and  |   | 5\. The application  |   | applicant, if        |   |
| a timetable for      |   | may also include a   |   | appropriate***;      |   |
| proposed actions by  |   | justification for    |   |                      |   |
| the applicant.       |   | not considering      |   | *(ea**) where the    |   |
|                      |   | risks to human       |   | analysis referred to |   |
| \(c\) a              |   | health and the       |   | in paragraph (e)     |   |
| justification for    |   | environment arising  |   | shows that suitable  |   |
| not considering      |   | either from:         |   | alternatives are     |   |
| risks to human       |   |                      |   | available, taking    |   |
| health and the       |   | \(i\) emissions of a |   | into account the     |   |
| environment arising  |   | substance from an    |   | elements in Article  |   |
| either from:         |   | installation for     |   | 59(4a), ~~and the    |   |
|                      |   | which a permit was   |   | risks are not        |   |
| \(i\) emissions of a |   | granted in           |   | adequately           |   |
| substance from an    |   | accordance with      |   | controlled~~, a      |   |
| installation for     |   | Directive 96/61/EC;  |   | substitution plan    |   |
| which a permit was   |   | or                   |   | including a          |   |
| granted in           |   |                      |   | timetable for        |   |
| accordance with      |   | \(ii\) discharges of |   | proposed actions by  |   |
| Council Directive    |   | a substance from a   |   | the applicant.***    |   |
| 96/61/EC; or         |   | point source         |   |                      |   |
|                      |   | governed by the      |   | 5\. The application  |   |
| \(ii\) discharges of |   | requirement for      |   | may include:         |   |
| a substance from a   |   | prior regulation     |   |                      |   |
| point source         |   | referred to in       |   | \(a\) a              |   |
| governed by the      |   | Article 11(3)(g) of  |   | socio-economic       |   |
| requirement for      |   | Directive 2000/60/EC |   | analysis conducted   |   |
| prior regulation     |   | and legislation      |   | in accordance with   |   |
| referred to in       |   | adopted under        |   | Annex XVI;           |   |
| Article 11(3)(g) of  |   | Article 16 of that   |   |                      |   |
| Directive 2000/60/EC |   | Directive.           |   | ~~(b) where *not     |   |
| and legislation      |   |                      |   | required under       |   |
| adopted under        |   | 6\. The application  |   | paragraph 4(ea),* a  |   |
| Article 16 of that   |   | shall not include    |   | substitution plan,   |   |
| Directive.           |   | the risks to human   |   | including research   |   |
|                      |   | health arising from  |   | and development and  |   |
| 6\. The application  |   | the use of a         |   | a timetable for      |   |
| shall not include    |   | substance in a       |   | proposed actions by  |   |
| the risks to human   |   | medical device       |   | the applicant;~~     |   |
| health arising from  |   | regulated by         |   |                      |   |
| the use of a         |   | Di                   |   | \(b\) a              |   |
| substance in a       |   | rectives 90/385/EEC, |   | justification for    |   |
| medical device       |   | 93/42/EEC or         |   | not considering      |   |
| regulated by         |   | 98/79/EC.            |   | risks to human       |   |
| Di                   |   |                      |   | health and the       |   |
| rectives 90/385/EEC, |   | 7\. An application   |   | environment arising  |   |
| 93/42/EEC or         |   | for an authorisation |   | either from:         |   |
| 98/79/EC.            |   | shall be accompanied |   |                      |   |
|                      |   | by the fee required  |   | \(i\) emissions of a |   |
| 7\. An application   |   | in accordance with   |   | substance from an    |   |
| for an authorisation |   | Title IX.            |   | installation for     |   |
| shall be accompanied |   |                      |   | which a permit was   |   |
| by the fee required  |   |                      |   | granted in           |   |
| in accordance with   |   |                      |   | accordance with      |   |
| Title IX.            |   |                      |   | Directive 96/61/EC;  |   |
|                      |   |                      |   | or                   |   |
|                      |   |                      |   |                      |   |
|                      |   |                      |   | \(ii\) discharges of |   |
|                      |   |                      |   | a substance from a   |   |
|                      |   |                      |   | point source         |   |
|                      |   |                      |   | governed by the      |   |
|                      |   |                      |   | requirement for      |   |
|                      |   |                      |   | prior regulation     |   |
|                      |   |                      |   | referred to in       |   |
|                      |   |                      |   | Article 11(3)(g) of  |   |
|                      |   |                      |   | Directive 2000/60/EC |   |
|                      |   |                      |   | and legislation      |   |
|                      |   |                      |   | adopted under        |   |
|                      |   |                      |   | Article 16 of that   |   |
|                      |   |                      |   | Directive.           |   |
|                      |   |                      |   |                      |   |
|                      |   |                      |   | 6\. -- 7.            |   |
|                      |   |                      |   | \[unchanged\]        |   |
+----------------------+---+----------------------+---+----------------------+---+
| Article 62           | D |                      | I |                      |   |
|                      | o |                      | n |                      |   |
| 1\. If an            | e |                      | r |                      |   |
| application has been | s |                      | e |                      |   |
| made for a use of a  | n |                      | s |                      |   |
| substance, a         | o |                      | p |                      |   |
| subsequent applicant | t |                      | o |                      |   |
| may refer to the     | e |                      | n |                      |   |
| parts of the         | x |                      | s |                      |   |
| previous application | i |                      | e |                      |   |
| submitted in         | s |                      | t |                      |   |
| accordance with      | t |                      | o |                      |   |
| Article 61(4)(d)     |   |                      | v |                      |   |
| and (5)(a) and (b),  |   |                      | a |                      |   |
| provided that the    |   |                      | r |                      |   |
| subsequent applicant |   |                      | i |                      |   |
| has permission from  |   |                      | o |                      |   |
| the previous         |   |                      | u |                      |   |
| applicant to refer   |   |                      | s |                      |   |
| to these parts of    |   |                      | a |                      |   |
| the application.     |   |                      | m |                      |   |
|                      |   |                      | e |                      |   |
| 2\. If an            |   |                      | n |                      |   |
| authorisation has    |   |                      | d |                      |   |
| been granted for a   |   |                      | m |                      |   |
| use of a substance,  |   |                      | e |                      |   |
| a subsequent         |   |                      | n |                      |   |
| applicant may refer  |   |                      | t |                      |   |
| to the parts of the  |   |                      | s |                      |   |
| holder\'s            |   |                      | v |                      |   |
| application          |   |                      | o |                      |   |
| submitted in         |   |                      | t |                      |   |
| accordance with      |   |                      | e |                      |   |
| Article 61(4)(d)     |   |                      | d |                      |   |
| and (5)(a) and (b),  |   |                      | i |                      |   |
| provided that the    |   |                      | n |                      |   |
| subsequent applicant |   |                      | t |                      |   |
| has permission from  |   |                      | h |                      |   |
| the holder of the    |   |                      | e |                      |   |
| authorisation to     |   |                      | E |                      |   |
| refer to these parts |   |                      | u |                      |   |
| of the application.  |   |                      | r |                      |   |
|                      |   |                      | o |                      |   |
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+----------------------+---+----------------------+---+----------------------+---+

+-----------------------+-----------------------+-----------------------+
| Article 63.2          | Does not exist        | In response to        |
|                       |                       | various amendments    |
| 2\. The Agency shall  |                       | voted in the European |
| make available on its |                       | Parliament, the       |
| web-site broad        |                       | Presidency suggests   |
| information on uses,  |                       | that Article 63.2 be  |
| taking into account   |                       | modified as follows:  |
| Articles 117 and 118  |                       |                       |
| on access to          |                       | 2\. The Agency shall  |
| information, for      |                       | make available on its |
| which applications    |                       | web-site broad        |
| have been received,   |                       | information on uses,  |
| with a deadline by    |                       | taking into account   |
| which information on  |                       | Articles 117 and 118  |
| alternative           |                       | on access to          |
| substances or         |                       | information, for      |
| technologies may be   |                       | which applications    |
| submitted by          |                       | have been received,   |
| interested third      |                       | ***and for reviews of |
| parties.              |                       | authorisations***,    |
|                       |                       | with a deadline by    |
|                       |                       | which information on  |
|                       |                       | alternative           |
|                       |                       | substances or         |
|                       |                       | technologies may be   |
|                       |                       | submitted by          |
|                       |                       | interested third      |
|                       |                       | parties.              |
+-----------------------+-----------------------+-----------------------+
| Article 63.4          | Amendment 112         | It was agreed that    |
|                       |                       | Article 63(4) should  |
| 4\. The draft         | 4\. The draft         | be modified as        |
| opinions shall        | opinions shall        | follows:              |
| include the following | include the following |                       |
| elements:             | elements:             | 4\. The draft         |
|                       |                       | opinions shall        |
| \(a\) Committee for   | \(a\) Committee for   | include the following |
| Risk Assessment: an   | Risk Assessment: an   | elements:             |
| assessment of the     | assessment of the     |                       |
| risk to human health  | risk to human health  | \(a\) Committee for   |
| and/or the            | and/or the            | Risk Assessment: an   |
| environment arising   | environment arising   | assessment of the     |
| from the use(s) of    | from the use(s) of    | risk to human health  |
| the substance as      | the substance as      | and/or the            |
| described in the      | described in the      | environment arising   |
| application and***,   | application and an    | from the use(s) of    |
| if relevant,*** an    | assessment of the     | the substance***,     |
| assessment of the     | risks arising from    | including the         |
| risks arising from    | possible              | appropriateness and   |
| possible              | alternatives;         | effectiveness of the  |
| alternatives;         |                       | risk management       |
|                       | \(b\) Committee for   | measures,*** as       |
| \(b\) Committee for   | Socio-economic        | described in the      |
| Socio-economic        | Analysis: an          | application and, if   |
| Analysis: an          | assessment of the     | relevant, an          |
| assessment of the     | socio-economic        | assessment of the     |
| socio-economic        | factors and the       | risks arising from    |
| factors and the       | availability,         | possible              |
| availability,         | suitability and       | alternatives;         |
| suitability and       | technical feasibility |                       |
| technical feasibility | of alternatives       | \(b\) Committee for   |
| of alternatives       | associated with the   | Socio-economic        |
| associated with the   | use(s) of the         | Analysis: an          |
| use(s) of the         | substance as          | assessment of the     |
| substance as          | described in the      | socio-economic        |
| described in the      | application.          | factors and the       |
| application***, when  |                       | availability,         |
| an application is     |                       | suitability and       |
| made in accordance    |                       | technical feasibility |
| with                  |                       | of alternatives       |
| Article 61(5)***.     |                       | associated with the   |
|                       |                       | use(s) of the         |
|                       |                       | substance as          |
|                       |                       | described in the      |
|                       |                       | application, when an  |
|                       |                       | application is made   |
|                       |                       | in accordance with    |
|                       |                       | Article 61~~(5)~~***, |
|                       |                       | and of any third      |
|                       |                       | party contributions   |
|                       |                       | submitted under       |
|                       |                       | paragraph 2***.       |
+-----------------------+-----------------------+-----------------------+
|                       |                       | It was agreed that    |
|                       |                       | paragraph 9 of        |
|                       |                       | Article 63 should be  |
|                       |                       | modified as           |
|                       |                       | f                     |
|                       |                       | ollows[:]{.underline} |
|                       |                       |                       |
|                       |                       | 9\. Summaries of the  |
|                       |                       | Commission decisions, |
|                       |                       | including the         |
|                       |                       | authorisation         |
|                       |                       | number***, and        |
|                       |                       | reasons of the        |
|                       |                       | decision, in          |
|                       |                       | particular, where     |
|                       |                       | suitable alternatives |
|                       |                       | exist,*** shall be    |
|                       |                       | published in the      |
|                       |                       | Official Journal of   |
|                       |                       | the European Union    |
|                       |                       | and shall be made     |
|                       |                       | publicly available in |
|                       |                       | a database            |
|                       |                       | established and kept  |
|                       |                       | up to date by the     |
|                       |                       | Agency.               |
+-----------------------+-----------------------+-----------------------+

**8. OTHER ISSUES**

**8.1 Intellectual Property Rights**

+-----------------------+-----------------------+----------------------+
| **Council Common      | **EP Amendment**      | **Result of the 6th  |
| Position**            |                       | trilogue**           |
+-----------------------+-----------------------+----------------------+
| Article 9.2           | Amendment 139 (as     | It was agreed to     |
|                       | tabled for ENVI       | address the concern  |
| 2\. For the purpose   | Committee)            | by modifying         |
| of paragraph 1, the   |                       | paragraph 7 of       |
| manufacturer or       | 2\. For the purpose   | Article 9 as         |
| importer or producer  | of paragraph 1, the   | follows:             |
| of articles shall     | manufacturer or       |                      |
| notify the Agency of  | importer or producer  | 7.  The Agency may   |
| the following         | of articles shall     | decide to extend the |
| information:          | notify the Agency of  | five-year exemption  |
|                       | the following         | period by a further  |
| \(a\) the identity of | information ***for    | maximum of five      |
| the manufacturer or   | substances that are   | years or, in the     |
| importer or producer  | placed on the         | case of substances   |
| of articles as        | market***:            | to be used           |
| specified in section  |                       | exclusively in the   |
| 1 of Annex VI;        | \(a\) the identity of | development of       |
|                       | the manufacturer or   | medicinal products   |
| \(b\) the identity of | importer or producer  | for human or         |
| the substance, as     | of articles as        | veterinary use ***or |
| specified in section  | specified in section  | for substances that  |
| 2 of Annex VI;        | 1 of Annex VI;        | are not placed on    |
|                       |                       | the market***, for a |
| \(c\) the             | \(b\) the identity of | further maximum of   |
| classification of the | the substance, as     | ten years, upon      |
| substance as          | specified in section  | request if the       |
| specified in section  | 2 of Annex VI;        | manufacturer or      |
| 4 of Annex VI, if     |                       | importer or producer |
| any;                  | \(c\) the             | of articles can      |
|                       | classification of the | demonstrate that     |
| \(d\) the estimated   | substance as          | such an extension is |
| quantity as specified | specified in section  | justified by the     |
| in section 3.1 of     | 4 of Annex VI, if     | research and         |
| Annex VI;             | any;                  | development          |
|                       |                       | programme.           |
| \(e\) the list of     | \(d\) the estimated   |                      |
| customers referred to | quantity as specified |                      |
| in paragraph 1,       | in section 3.1 of     |                      |
| including their names | Annex VI;             |                      |
| and addresses.        |                       |                      |
|                       | \(e\) ***if           |                      |
| The notification      | relevant,*** the list |                      |
| shall be accompanied  | of customers to       |                      |
| by the fee required   | ***which the          |                      |
| in accordance with    | substance if being    |                      |
| Title IX.             | supplied***.          |                      |
|                       |                       |                      |
| The period set out in | The notification      |                      |
| paragraph 1 shall     | shall be accompanied  |                      |
| begin at receipt of   | by the fee required   |                      |
| the notification at   | in accordance with    |                      |
| the Agency.           | Title IX.             |                      |
|                       |                       |                      |
|                       | The period set out in |                      |
|                       | paragraph 1 shall     |                      |
|                       | begin at receipt of   |                      |
|                       | the notification at   |                      |
|                       | the Agency.           |                      |
+-----------------------+-----------------------+----------------------+

+-----------------------+-----------------------+----------------------+
| Article 117.2.d       | Amendment 302 (as     | It was agreed that   |
|                       | tabled for ENVI       | points (b) and (e)   |
| \(d\) links between a | Committee)            | of Article 117.2     |
| manufacturer or       |                       | should be modified   |
| importer and his      | \(d\) links between a | as follows:          |
| downstream users.     | manufacturer or       |                      |
|                       | importer and his      | \(b\) ***without     |
|                       | downstream users      | prejudice to Article |
|                       | ***and his retailers  | 7(6) and Article     |
|                       | involved***.          | 63(2),*** the        |
|                       |                       | precise use,         |
|                       | ***(da) any           | function or          |
|                       | information on        | application of a     |
|                       | onsite-isolated and   | substance or         |
|                       | transported isolated  | preparation**,       |
|                       | intermediates.***     | *including precise   |
|                       |                       | information about    |
|                       |                       | use as an            |
|                       |                       | intermediate***;     |
|                       |                       |                      |
|                       |                       | \(d\) links between  |
|                       |                       | a manufacturer or    |
|                       |                       | importer and his     |
|                       |                       | ***distributors      |
|                       |                       | or*** downstream     |
|                       |                       | users.               |
+-----------------------+-----------------------+----------------------+
| Does not exist        | Amendment 303 (as     | It was agreed that   |
|                       | tabled for ENVI       | Amendment 303 (ENVI) |
|                       | Committee)            | should be taken into |
|                       |                       | account by           |
|                       | Article 117. 4 (A)    | introducing a new    |
|                       | and (B)(NEW)          | Recital as follows:  |
|                       |                       |                      |
|                       | ***4a. Whenever a     | **Recital (New)**    |
|                       | request for access to |                      |
|                       | documents* for *which | ***Disclosure of     |
|                       | the applicant has     | information under    |
|                       | requested             | this Regulation is   |
|                       | confidentiality is    | subject to the       |
|                       | made under Regulation | specific             |
|                       | (EC) No 1049/2001 to  | requirements of      |
|                       | the Agency, the       | Regulation 1049/2001 |
|                       | Agency shall perform  | on public access to  |
|                       | the consultation of   | documents held by    |
|                       | the third party       | the Community        |
|                       | provided for in       | Institutions. The    |
|                       | Article 4(4) of       | Regulation sets      |
|                       | Regulation (EC) No    | binding deadlines    |
|                       | 1049/2001 in          | for the release of   |
|                       | accordance with the   | information as well  |
|                       | second and third      | as procedural        |
|                       | subparagraphs.***     | guarantees,          |
|                       |                       | including the right  |
|                       | ***The Agency shall   | of appeal. The       |
|                       | inform the registrant | Management Board     |
|                       | and, where            | should adopt the     |
|                       | appropriate, the      | practical            |
|                       | potential registrant, | arrangements for     |
|                       | downstream user or    | application of these |
|                       | other party concerned | requirements to the  |
|                       | of this request.***   | Agency.***           |
|                       |                       |                      |
|                       | ***The Agency shall   | [In addition, it was |
|                       | inform the applicant, | agreed to modify     |
|                       | as well as the        | paragraph 3 of       |
|                       | registrant, the       | Article 117 as       |
|                       | potential registrant, | f                    |
|                       | the downstream user   | ollows:]{.underline} |
|                       | or other party        |                      |
|                       | concerned of its      | *[Article            |
|                       | decision with regard  | 117]{.underline}*    |
|                       | to the application    |                      |
|                       | for access to the     | 3\. The management   |
|                       | documents. Any of     | board shall adopt    |
|                       | these may, in         | the practical        |
|                       | accordance with       | arrangements for     |
|                       | Articles 87, 88 and   | implementing         |
|                       | 89, appeal to the     | Regulation (EC) No   |
|                       | Board of Appeal       | 1049/20              |
|                       | against that          | 01***[,]{.underline} |
|                       | decision, within 15   | including appeals or |
|                       | days of the decision. | remedies [necessary  |
|                       | Such an appeal shall  | for]{.underline}     |
|                       | have suspensive       | reviewing a partial  |
|                       | effect. The Board of  | or full rejection of |
|                       | Appeal shall decide   | a confidentiality    |
|                       | on the appeal within  | reque                |
|                       | 30 days.***           | st[,]{.underline}*** |
|                       |                       | by \.....\*          |
|                       | ***4b. While an       |                      |
|                       | appeal is pending or  | *[\* 12 months after |
|                       | while an appeal may   | entry into force of  |
|                       | yet be introduced,    | this                 |
|                       | the Agency and any    | Regul                |
|                       | competent authority   | ation.]{.underline}* |
|                       | of a Member State     |                      |
|                       | shall continue to     |                      |
|                       | keep the information  |                      |
|                       | in question           |                      |
|                       | confidential.***      |                      |
+-----------------------+-----------------------+----------------------+
| Article 118           | Amendment 304 (as     | It was agreed that   |
|                       | tabled for ENVI       | the text should be   |
| 1\. The following     | Committee)            | modified as follows: |
| information held by   |                       |                      |
| the Agency on         | 1\. The following     | *Article 118*        |
| substances whether on | information held by   |                      |
| their own, in         | the Agency on         | *Electronic public   |
| preparations or in    | substances whether on | access*              |
| articles, shall be    | their own, in         |                      |
| made publicly         | preparations or in    | 1\. The following    |
| available, free of    | articles, shall       | information held by  |
| charge, over the      | usually be made       | the Agency on        |
| Internet in           | publicly available,   | substances whether   |
| accordance with       | free of charge, over  | on their own, in     |
| Article 76(2)(d):     | the Internet in       | preparations or in   |
|                       | accordance with       | articles, shall be   |
| \(a\) the trade       | Article 76(2)(d):\    | made publicly        |
| name(s) of the        | **deleted\            | available, free of   |
| substance;\           | deleted**\            | charge, over the     |
| (b) the name in the   | (c) if applicable,    | Internet in          |
| IUPAC Nomenclature,   | the name of the       | accordance with      |
| for dangerous         | substance as given in | Article 76(2)(d):    |
| substances within the | EINECS;\              |                      |
| meaning of            | (d) the               | ~~(a) the trade      |
| D                     | classification and    | name(s) of the       |
| irective 67/548/EEC;\ | labelling of the      | substance;~~\        |
| (c) if applicable,    | substance;\           | (b) the name in the  |
| the name of the       | (e) physicochemical   | IUPAC Nomenclature,  |
| substance as given in | data concerning the   | for dangerous        |
| EINECS;\              | substance and on      | substances within    |
| (d) the               | pathways and          | the meaning of       |
| classification and    | environmental fate;\  | Directive 67/548/EEC |
| labelling of the      | (f) the result of     | without prejudice to |
| substance;\           | each toxicological    | paragraph ***2(da),  |
| (e) physicochemical   | and ecotoxicological  | 2(db), and 2(dc);\   |
| data concerning the   | study;\               | *** (c) if           |
| substance and on      | (g) any derived       | applicable, the name |
| pathways and          | no-effect level       | of the substance as  |
| environmental fate;\  | (DNEL) or predicted   | given in EINECS;\    |
| (f) the result of     | no-effect             | (d) the              |
| each toxicological    | concentration (PNEC)  | classification and   |
| and ecotoxicological  | established in        | labelling of the     |
| study;\               | accordance with       | substance;\          |
| (g) any derived       | Annex I;\             | (e) physicochemical  |
| no-effect level       | (h) the guidance on   | data concerning the  |
| (DNEL) or predicted   | safe use provided in  | substance and on     |
| no-effect             | accordance with       | pathways and         |
| concentration (PNEC)  | sections 4 and 5 of   | environmental fate;\ |
| established in        | Annex VI;\            | (f) the result of    |
| accordance with       | (i) analytical        | each toxicological   |
| Annex I;\             | methods if requested  | and ecotoxicological |
| (h) the guidance on   | in accordance with    | study;\              |
| safe use provided in  | Annexes IX or X which | (g) any derived      |
| accordance with       | make it possible to   | no-effect level      |
| sections 4 and 5 of   | detect a dangerous    | (DNEL) or predicted  |
| Annex VI;\            | substance when        | no-effect            |
| (i) analytical        | discharged into the   | concentration (PNEC) |
| methods if requested  | environment as well   | established in       |
| in accordance with    | as to determine the   | accordance with      |
| Annexes IX or X which | direct exposure of    | Annex I;\            |
| make it possible to   | humans.               | (h) the guidance on  |
| detect a dangerous    |                       | safe use provided in |
| substance when        | 2\. The following     | accordance with      |
| discharged into the   | information on        | sections 4 and 5 of  |
| environment as well   | substances whether on | Annex VI;\           |
| as to determine the   | their own, in         | (i) analytical       |
| direct exposure of    | preparations or in    | methods if requested |
| humans.               | articles, shall be    | in accordance with   |
|                       | made publicly         | Annexes IX or X      |
| 2\. The following     | available, free of    | which make it        |
| information on        | charge, over the      | possible to detect a |
| substances whether on | Internet in           | dangerous substance  |
| their own, in         | accordance with       | when discharged into |
| preparations or in    | Article 76(2)(d)      | the environment as   |
| articles, shall be    | except where a party  | well as to determine |
| made publicly         | submitting the        | the direct exposure  |
| available, free of    | information submits a | of humans.           |
| charge, over the      | justification         |                      |
| Internet in           | accepted as valid by  | 2\. The following    |
| accordance with       | the Agency, as to why | information on       |
| Article 76(2)(d)      | such publication is   | substances whether   |
| except where a party  | potentially harmful   | on their own, in     |
| submitting the        | for the commercial    | preparations or in   |
| information submits a | interests of the      | articles, shall be   |
| justification in      | registrant or any     | made publicly        |
| accordance with       | other party           | available, free of   |
| Article 10(a)(xi),    | concerned:\           | charge, over the     |
| accepted as valid by  | (a) if essential to   | Internet in          |
| the Agency, as to why | classification and    | accordance with      |
| such publication is   | labelling, the degree | Article 76(2)(d)     |
| potentially harmful   | of purity of the      | except where a party |
| for the commercial    | substance and the     | submitting the       |
| interests of the      | identity of           | information submits  |
| registrant or any     | impurities and/or     | a justification in   |
| other party           | additives which are   | accordance with      |
| concerned:\           | known to be           | Article 10(a)(xi),   |
| (a) if essential to   | dangerous;\           | accepted as valid by |
| classification and    | (b) the total tonnage | the Agency, as to    |
| labelling, the degree | band (i.e. 1-10       | why such publication |
| of purity of the      | tonnes, 10-100        | is potentially       |
| substance and the     | tonnes,               | harmful for the      |
| identity of           | 100-1 000 tonnes or   | commercial interests |
| impurities and/or     | over 1 000 tonnes)    | of the registrant or |
| additives which are   | within which a        | any other party      |
| known to be           | particular substance  | concerned:\          |
| dangerous;\           | has been registered;\ | (a) if essential to  |
| (b) the total tonnage | (c) the study         | classification and   |
| band (i.e. 1-10       | summaries or robust   | labelling, the       |
| tonnes, 10-100        | study summaries of    | degree of purity of  |
| tonnes,               | the information       | the substance and    |
| 100-1 000 tonnes or   | referred to in        | the identity of      |
| over 1 000 tonnes)    | paragraph 1(e) and    | impurities and/or    |
| within which a        | (f);\                 | additives which are  |
| particular substance  | (d) information,      | known to be          |
| has been registered;\ | other than that       | dangerous;\          |
| (c) the study         | listed in paragraph   | (b) the total        |
| summaries or robust   | 1, contained in the   | tonnage band (i.e.   |
| study summaries of    | safety data sheet;\   | 1-10 tonnes, 10-100  |
| the information       | **(da) the trade      | tonnes,              |
| referred to in        | name(s) of the        | 100-1 000 tonnes or  |
| paragraph 1(e) and    | substance;**          | over 1 000 tonnes)   |
| (f);\                 |                       | within which a       |
| (d) information,      | **(b) the name in the | particular substance |
| other than that       | IUPAC Nomenclature,   | has been             |
| listed in paragraph   | for dangerous         | registered;\         |
| 1, contained in the   | substances within the | (c) the study        |
| safety data sheet.    | meaning of            | summaries or robust  |
|                       | D                     | study summaries of   |
|                       | irective 67/548/EEC;\ | the information      |
|                       | **\                   | referred to in       |
|                       | **2a. In justified    | paragraph 1(e) and   |
|                       | special cases the     | (f);\                |
|                       | information in        | (d) information,     |
|                       | paragraph 1 may be    | other than that      |
|                       | exempted from the     | listed in paragraph  |
|                       | electronic public     | 1, contained in the  |
|                       | access, if the a      | safety data sheet;   |
|                       | party submitting the  |                      |
|                       | information proofed   | ***(da) the trade    |
|                       | to the Agency that    | name(s) of the       |
|                       | his commercial        | substance;***        |
|                       | interests, or         |                      |
|                       | interests on          | ***(db) the name in  |
|                       | scientific research   | the IUPAC            |
|                       | and development are   | Nomenclature for     |
|                       | potentially harmed by | non-phase-in         |
|                       | such a publication.** | substances which are |
|                       |                       | dangerous within the |
|                       |                       | meaning of           |
|                       |                       | Directive 67/548/EEC |
|                       |                       | for a period of      |
|                       |                       | [six]{.underline}    |
|                       |                       | years;***            |
|                       |                       |                      |
|                       |                       | ***(dc) the name in  |
|                       |                       | the IUPAC            |
|                       |                       | Nomenclature for     |
|                       |                       | dangerous substances |
|                       |                       | within the meaning   |
|                       |                       | of                   |
|                       |                       | Directive 67/548/EEC |
|                       |                       | that are only used   |
|                       |                       | as one or more of    |
|                       |                       | the following:***    |
|                       |                       |                      |
|                       |                       | ***(i) as an         |
|                       |                       | intermediate;***     |
|                       |                       |                      |
|                       |                       | ***(ii) in           |
|                       |                       | scientific research  |
|                       |                       | and development;***  |
|                       |                       |                      |
|                       |                       | ***(iii) in product  |
|                       |                       | and process          |
|                       |                       | orientated research  |
|                       |                       | and development.***  |
+-----------------------+-----------------------+----------------------+

**8.2 Technical issues**

+-----------------------+-----------------------+----------------------+
| **Council Common      | **EP amendment**      | **Result of the 6th  |
| Position**            |                       | trilogue**           |
+-----------------------+-----------------------+----------------------+
| Article 66.3          | Amendment 116         | It was agreed that   |
|                       |                       | the concern behind   |
| Until ...\* a Member  | Until ...\*, a Member | this amendment       |
| State may maintain    | State may maintain    | should be addressed  |
| any existing          | any existing ***or*** | by modifiying        |
| ***and*** more        | more stringent        | Articles 136, 138    |
| stringent             | restrictions ***as    | and 140 to read as   |
| restrictions in       | well as any           | below, and that      |
| relation to Annex     | implementing measures | Recital 73 should be |
| XVII on the           | thereof*** in         | modified as follows. |
| manufacture, placing  | relation to Annex     | In addition, it was  |
| on the market or use  | XVII on the           | agreed that the      |
| of a substance,       | manufacture, placing  | entry into force of  |
| provided that those   | on the market or use  | the Regulation be    |
| restrictions have     | of a substance,       | specified by means   |
| been notified         | provided that those   | of an accurate date. |
| according to the      | restrictions have     |                      |
| Treaty. The           | been notified         | Article 136\         |
| Commission shall      | according to the      | Transitional         |
| compile and publish   | Treaty. The           | measures regarding   |
| an inventory of these | Commission shall      | restrictions         |
| restrictions by       | compile and publish   |                      |
| ....\*\*              | an inventory of these | 1\. By...^\*^, the   |
|                       | restrictions by       | Commission shall, if |
| \_\_\_\_\_\_          | ...\*\*.              | necessary, prepare a |
|                       |                       | draft amendment to   |
| \* 6 years after      |                       | Annex XVII in        |
| entry into force of   |                       | accordance with      |
| this Regulation       |                       | either of the        |
|                       |                       | following:           |
| \*\* 2 years after    |                       |                      |
| entry into force of   |                       | \(a\) any risk       |
| this Regulation       |                       | evaluation and       |
|                       |                       | recommended strategy |
|                       |                       | for limiting risks   |
|                       |                       | that has been        |
|                       |                       | adopted at Community |
|                       |                       | level in accordance  |
|                       |                       | with Article 11 of   |
|                       |                       | Regulation (EEC)     |
|                       |                       | No 793/93 as far as  |
|                       |                       | it includes          |
|                       |                       | proposals for        |
|                       |                       | restrictions in      |
|                       |                       | accordance with      |
|                       |                       | Title VIII of this   |
|                       |                       | Regulation but for   |
|                       |                       | which a decision     |
|                       |                       | under Directive      |
|                       |                       | 76/769/EEC has not   |
|                       |                       | yet been taken;      |
|                       |                       |                      |
|                       |                       | \(b\) any proposal,  |
|                       |                       | which has been       |
|                       |                       | submitted to the     |
|                       |                       | relevant             |
|                       |                       | institutions but has |
|                       |                       | not yet been         |
|                       |                       | adopted, concerning  |
|                       |                       | the introduction     |
|                       |                       | ***or the            |
|                       |                       | amendment*** of      |
|                       |                       | restrictions under   |
|                       |                       | D                    |
|                       |                       | irective 76/769/EEC. |
|                       |                       |                      |
|                       |                       | 2\. Until...\*, any  |
|                       |                       | dossier referred to  |
|                       |                       | in Article 128(3)    |
|                       |                       | shall be submitted   |
|                       |                       | to the Commission.   |
|                       |                       | The Commission       |
|                       |                       | shall, if necessary, |
|                       |                       | prepare a draft      |
|                       |                       | amendment to         |
|                       |                       | Annex XVII.          |
|                       |                       |                      |
|                       |                       | ***3. Any amendment  |
|                       |                       | to the restrictions  |
|                       |                       | adopted under        |
|                       |                       | Directive 76/769/EEC |
|                       |                       | from \*\* shall be   |
|                       |                       | incorporated in      |
|                       |                       | Annex XVII with      |
|                       |                       | effect from          |
|                       |                       | \*\*\*.***           |
|                       |                       |                      |
|                       |                       | \_\_\_\_             |
|                       |                       |                      |
|                       |                       | \*                   |
|                       |                       | ~~18~~***[36]{.      |
|                       |                       | underline}*** months |
|                       |                       | after entry into     |
|                       |                       | force of this        |
|                       |                       | Regulation.          |
|                       |                       |                      |
|                       |                       | *^\*\*^ **Date of    |
|                       |                       | entry into force of  |
|                       |                       | this Regulation.***  |
|                       |                       |                      |
|                       |                       | *^\*\*\*^ **24       |
|                       |                       | months after entry   |
|                       |                       | into force of this   |
|                       |                       | Regulati             |
|                       |                       | on[.]{.underline}*** |
|                       |                       |                      |
|                       |                       | \_\_\_\_             |
|                       |                       | \_\_\_\_\_\_\_\_\_\_ |
|                       |                       |                      |
|                       |                       | Article 138\         |
|                       |                       | Repeals              |
|                       |                       |                      |
|                       |                       | Directive~~s         |
|                       |                       | 76/769/EEC and~~     |
|                       |                       | 91/155/EEC shall be  |
|                       |                       | repealed.            |
|                       |                       |                      |
|                       |                       | Directives 93/105/EC |
|                       |                       | and 2000/21/EC and   |
|                       |                       | Regulations (EEC) No |
|                       |                       | 793/93 and (EC) No   |
|                       |                       | 1488/94 shall be     |
|                       |                       | repealed with effect |
|                       |                       | from ....^\*^.       |
|                       |                       |                      |
|                       |                       | Directive 93/67/EEC  |
|                       |                       | shall be repealed    |
|                       |                       | with effect from     |
|                       |                       | ....\*\*             |
|                       |                       |                      |
|                       |                       | ***Directive         |
|                       |                       | 76/769/EEC shall be  |
|                       |                       | repealed with effect |
|                       |                       | from...\*\*\*.***    |
|                       |                       |                      |
|                       |                       | References to the    |
|                       |                       | repealed acts shall  |
|                       |                       | be construed as      |
|                       |                       | references to this   |
|                       |                       | Regulation.          |
|                       |                       |                      |
|                       |                       | \_\_\_\_             |
|                       |                       |                      |
|                       |                       | \* 12 months after   |
|                       |                       | entry into force of  |
|                       |                       | this Regulation.     |
|                       |                       |                      |
|                       |                       | **^\*\*^** 14 months |
|                       |                       | after entry into     |
|                       |                       | force of this        |
|                       |                       | Regulation.          |
|                       |                       |                      |
|                       |                       | **^\*\*\*^** 24      |
|                       |                       | months after entry   |
|                       |                       | into force of this   |
|                       |                       | Regulation           |
|                       |                       |                      |
|                       |                       | *Recital*            |
|                       |                       |                      |
|                       |                       | \(73\) In order to   |
|                       |                       | accelerate the       |
|                       |                       | current system, the  |
|                       |                       | restriction          |
|                       |                       | procedure should be  |
|                       |                       | restructured and     |
|                       |                       | D                    |
|                       |                       | irective 76/769/EEC, |
|                       |                       | which has been       |
|                       |                       | substantially        |
|                       |                       | amended and adapted  |
|                       |                       | several times,       |
|                       |                       | should be replaced.  |
|                       |                       | In the interests of  |
|                       |                       | clarity and as a     |
|                       |                       | starting point for   |
|                       |                       | this new accelerated |
|                       |                       | restriction          |
|                       |                       | procedure, ~~the     |
|                       |                       | *acquis* of the      |
|                       |                       | harmonised rules~~   |
|                       |                       | ***all the           |
|                       |                       | restrictions***      |
|                       |                       | ***developed         |
|                       |                       | under*** ~~under the |
|                       |                       | Annex to~~           |
|                       |                       | th***[e]{            |
|                       |                       | .underline}***~~at~~ |
|                       |                       | Directive should be  |
|                       |                       | ~~recast and taken   |
|                       |                       | over~~               |
|                       |                       | ***incorporated into |
|                       |                       | this                 |
|                       |                       | Regulation***~~.     |
|                       |                       | This recast follows  |
|                       |                       | the rules set out    |
|                       |                       | within the           |
|                       |                       | Interinstitutional   |
|                       |                       | Agreement of 28      |
|                       |                       | November 2001 on a   |
|                       |                       | more structured use  |
|                       |                       | of the recasting     |
|                       |                       | technique for legal  |
|                       |                       | texts concerning     |
|                       |                       | recasting            |
|                       |                       | techniques~~.        |
|                       |                       | ***Where             |
|                       |                       | appropriate, the     |
|                       |                       | application of Annex |
|                       |                       | XVII should be       |
|                       |                       | facilitated by       |
|                       |                       | guidance developed   |
|                       |                       | by the Commission[.  |
|                       |                       | ]{.underline}***     |
|                       |                       |                      |
|                       |                       | \_\_\_\_             |
|                       |                       |                      |
|                       |                       | The Presidency       |
|                       |                       | suggests to modify   |
|                       |                       | Paragraph 1 of       |
|                       |                       | Article 140 as       |
|                       |                       | follows:             |
|                       |                       |                      |
|                       |                       | *Article 140*        |
|                       |                       |                      |
|                       |                       | *Entry into force    |
|                       |                       | and application*     |
|                       |                       |                      |
|                       |                       | 1\. This Regulation  |
|                       |                       | shall enter into     |
|                       |                       | force on ***1^st^ of |
|                       |                       | June, 2007***        |
|                       |                       | ~~twentieth day      |
|                       |                       | following that of    |
|                       |                       | its publication in   |
|                       |                       | the Official Journal |
|                       |                       | of the European      |
|                       |                       | Union~~.             |
|                       |                       |                      |
|                       |                       | 2\. Titles II, III,  |
|                       |                       | V, VI, VII, XI and   |
|                       |                       | XII as well as       |
|                       |                       | Articles 127 and 135 |
|                       |                       | shall apply from     |
|                       |                       | ...\*.               |
|                       |                       |                      |
|                       |                       | 3\. Article 134      |
|                       |                       | shall apply from     |
|                       |                       | ...\*\*.             |
|                       |                       |                      |
|                       |                       | 4\. Title VIII and   |
|                       |                       | Annex XVII shall     |
|                       |                       | apply from           |
|                       |                       | ...\*\*\*.           |
|                       |                       |                      |
|                       |                       | \_\_\_\_             |
|                       |                       |                      |
|                       |                       | **^\*^** 12 months   |
|                       |                       | after entry into     |
|                       |                       | force of this        |
|                       |                       | Regulation.          |
|                       |                       |                      |
|                       |                       | **^\*\*^** 14 months |
|                       |                       | after entry into     |
|                       |                       | force of this        |
|                       |                       | Regulation.          |
|                       |                       |                      |
|                       |                       | **^\*\*\*^**         |
|                       |                       | ~~18~~**             |
|                       |                       | *[24]{.underline}*** |
|                       |                       | months after entry   |
|                       |                       | into force of this   |
|                       |                       | Regulation           |
|                       |                       |                      |
|                       |                       | \_\_\_\_             |
+-----------------------+-----------------------+----------------------+
|                       | EP amendments on the  | It was agreed that   |
|                       | scope: AM 31, AM      | the Commission will  |
|                       | 99(ENVI), AM 100      | review the scope of  |
|                       | (ENVI), AM 101        | the Regulation as    |
|                       | (ENVI), AM 102        | regards the          |
|                       | (ENVI), AM 104        | interface with other |
|                       | (ENVI), AM 108(ENVI), | pieces of Community  |
|                       | AM 109(ENVI), AM110   | legislation. The     |
|                       | (ENVI), AM111(ENVI),  | proposed review is   |
|                       | AM112 (ENVI)          | intended to respond  |
|                       |                       | to amendments on the |
|                       |                       | scope.               |
|                       |                       |                      |
|                       |                       | **Article 137\       |
|                       |                       | Review**             |
|                       |                       |                      |
|                       |                       | ***1(b). By ...\*,   |
|                       |                       | the Commission shall |
|                       |                       | carry out a review   |
|                       |                       | to assess whether or |
|                       |                       | not to amend the     |
|                       |                       | scope of this        |
|                       |                       | Regulation to avoid  |
|                       |                       | overlaps with other  |
|                       |                       | relevant Community   |
|                       |                       | provisions. On the   |
|                       |                       | basis of this        |
|                       |                       | review, the          |
|                       |                       | Commission may, if   |
|                       |                       | appropriate, present |
|                       |                       | a legislative        |
|                       |                       | proposal.***         |
|                       |                       |                      |
|                       |                       | ***\* 5 years after  |
|                       |                       | entry into force of  |
|                       |                       | this Regulation.***  |
+-----------------------+-----------------------+----------------------+
| Annex XVII            | Amendment 172         | It was agreed to     |
| (Restrictions on the  |                       | update Annex XVII to |
| manufacture, placing  | ANNEX XVII, POINT 47  | indicate all         |
| on the market and use | A, B, C, D, E (new)   | amendments and       |
| of certain dangerous  |                       | technical            |
| substances,           | ( Annex D, not        | adaptations          |
| preparations and      | included in this      | introduced to        |
| articles)             | table)                | Directive 76/769/EEC |
|                       |                       | since adoption of    |
|                       |                       | the proposal for     |
|                       |                       | REACH Regulation.    |
|                       |                       | The updated Annex    |
|                       |                       | XVII IS AVAILABLE    |
|                       |                       | BUT NOT INCLUDED IN  |
|                       |                       | THIS DOCUMENT, more  |
|                       |                       | than 300 pages.      |
+-----------------------+-----------------------+----------------------+

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

**[ANNEX B]{.underline}**

***Commission Statement on Alternative Methods:***

***As part of the Community's strategy to promote alternative test
methods, the development of methods covering computer supported, in
vitro and other methodologies, including refinement of current methods,
has been a priority for decades. Between 1999 and 2002 (Fifth Framework
Programme), the EU supported 43 research projects worth €65 million,
several of which are still ongoing. In the current Research Framework
Programme (Sixth Framework Programme: 2003-2006), the European Union is
investing more than €90 million to develop robust, effective, non-animal
testing methods that will withstand the requirements of international
validation.***

***Research activities will continue in the forthcoming Seventh
Framework Programme (2007-2013) through coordinated activities on
alternative methods and strategies for safety testing focused on
pharmaceuticals (under the Health theme) and industrial chemicals (under
the Environment theme). Consideration has been given to which methods
could make the most contribution to reducing animal testing within
REACH, taking due account of the time needed to develop tests and the
relevant registration deadlines in REACH. As a result, the Seventh
Framework Programme includes development of methods that could directly
support the reduction of animals used in testing within REACH.
Involvement of stakeholders is being sought through initiatives such as
the European Partnership for Alternative Approaches to Animal Testing,
launched on November 7, 2005 by Commissioners Potocnik and Verheugen
together with industry. By effectively pooling Commission and industry
experience, expertise and resources, a common coordinated Partnership at
EU level and across sectors will be more effective than historically
fragmented initiatives in this area.***

***The validation of alternative testing methods has been a priority for
the Commission since 1991. To this end, the Commission set up the
European Centre for the Validation of Alternative Methods (ECVAM), a
specific unit within the Joint Research Centre with the task of
coordinating the validation of alternative test methods at the European
Union level, and promoting the development, validation and international
recognition of alternative test methods.*** ***The Commission will
continue to validate appropriate methods and will consider the
application of validated methods in Community legislation. Today,
suitable methods are used in the context of the Community legislation on
chemicals, to adapt the Annex V of Directive 67/548/EEC. The Commission
recognises the importance of securing regulatory acceptance for such
methods as rapidly as possible and has adopted several validated
alternative test methods in Annex V of 67/548/EEC ahead of their
eventual international acceptance. The Commission will give a high
priority to ensuring that the REACH testing regulation is adapted as
soon as possible after appropriate validated methods become
available.***

***The Commission will continue to be active in international fora,
particularly the OECD where it contributes to the development of new
standards for tests and with especial focus on newly validated methods
as mentioned above.***

***The regulatory framework in which test methods are used is as
important as the specific methods. Since its very beginning, the
minimisation of animal testing has been a key element of the design of
REACH and the Commission has consistently worked to improve this aspect
of the proposal. This can be seen in terms of significant changes
throughout the process such as adding the pre-registration phase as a
result of feedback on the White Paper in 2001 and accepting a single
pre-registration date as proposed in both Parliament\'s First Reading
Opinion and the Council Common Position. Minimisation of animal testing
is also apparent in the detailed legal text, including encouragement for
grouping of substances, evaluation of testing proposals and use of read
across Important work related to reducing the use of animals is on-going
in the RIPs (REACH Implementation Projects) with the development of
intelligent testing strategies. The Commission is committed to
continuing this work after the adoption of REACH. For example the
development and maintenance of guidelines and Agency procedures will
offer further opportunities to address concerns over animal testing.***

***The Commission will also consider relevant aspects in the review of
Directive 86/609/EEC, specifically in relation to the ways in which the
development, validation and regulatory acceptance of alternative methods
in accordance with the \'Three Rs\' principle could be further
promoted.***

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

***ANNEX C***

***Commission declaration on tobacco Additives in the context of the
negotiations on REACH***

***and addressing the EP amendments on tobacco additives***

***The REACH Regulation covers chemical ingredients to tobacco products
like any other chemical substance. As such, they will need to be
registered and be subject to evaluation, restriction or authorisation
under the REACH system. Some of their effects in burnt form should be
covered by any required chemical safety assessments.***

***Once the REACH system is in operation, it will be necessary to
summarize and to take into account the information made available under
REACH on tobacco ingredients in order to better benefit from the
synergies with the on-going work in the context of Directive 2001/37/EC
on the approximation of the laws, regulations and administrative
provisions of the Member States concerning the manufacture, presentation
and sale of tobacco products.***

***In the context of Directive 2001/37/EC, the Commission is committed
to promote:***

***- the development and application of a harmonised reporting format
for tobacco ingredients in order to create a precondition for systematic
assessment of tobacco ingredients. This could evolve, at a later stage,
into the setting up of a European data bank on tobacco ingredients and
their effects;***

***- the assessment of tests for toxicological and addictive effects
from a public health perspective***

***- cooperation of independent tobacco laboratories within the EU in
order to create the operational basis for a shared analysis and
assessment of tobacco ingredients and/or smoke emissions by the Member
States, and subsequent consideration on the form of a possible proposal
for a common list of ingredients.***

***The Commission will also:***

***- participate in the process of developing guidelines on testing and
measuring of the contents and emissions of tobacco products in the
context of Framework Convention on Tobacco Control (FCTC), and***

***- consider co-financing research on toxicity and in particular
addictiveness of tobacco ingredients and/or smoke emissions in the
context of the research framework program.***

***By the next review of Directive 2001/37/EC, which will be based on
the report on its implementation due for the end of 2007, the Commission
will consider further development of the framework for the assessment of
tobacco ingredients in the light of the experience gathered and impact
assessments on different options.***

***The burden of proof on the health effects of the contents and
emissions of tobacco products should fully lie with the industry, which
should be responsible for the financing of the development, validation
and carrying out of the appropriate toxicological and addictiveness
tests. This process must be led by the public health authorities to
ensure that all the methodologies developed properly address public
health concerns.***

***On the basis of the principle established in the previous paragraph
concerning the role of the industry in financing the tests, the
Commission will examine the concrete options for raising adequate human
and financial resources in order to fund any substantial work programme
on evaluating ingredients and smoke emissions to properly assess the
results from a health perspective.***

***The Commission is aware that the development and validation of
methodologies and the evaluation of substances is a demanding task that
will take several years.***

\_\_\_\_\_\_\_\_\_\_\_\_\_\_