interactive GDPR 2016/0679 EN

1. Union or Member State law to which the data controller or processor is subject may restrict by way of a legislative measure the scope of the obligations and rights provided for in Articles 12 to 22 and Article 34, as well as Article 5 in so far as its provisions correspond to the rights and obligations provided for in Articles 12 to 22, when such a restriction respects the essence of the fundamental rights and freedoms and is a necessary and proportionate measure in a democratic society to safeguard:

(a)	national security;

(b)

defence;

(c)	public security;

(d)	the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, including the safeguarding against and the prevention of threats to public security;

(e)	other important objectives of general public interest of the Union or of a Member State, in particular an important economic or financial interest of the Union or of a Member State, including monetary, budgetary and taxation a matters, public health and social security;

(f)	the protection of judicial independence and judicial proceedings;

(g)	the prevention, investigation, detection and prosecution of breaches of ethics for regulated professions;

(h)	a monitoring, inspection or regulatory function connected, even occasionally, to the exercise of official authority in the cases referred to in points (a) to (e) and (g);

(i)	the protection of the data subject or the rights and freedoms of others;

(j)	the enforcement of civil law claims.

2. In particular, any legislative measure referred to in paragraph 1 shall contain specific provisions at least, where relevant, as to:

(a)	the purposes of the processing or categories of processing;

(b)	the categories of personal_data;

(c)	the scope of the restrictions introduced;

(d)	the safeguards to prevent abuse or unlawful access or transfer;

(e)	the specification of the controller or categories of controllers;

(f)	the storage periods and the applicable safeguards taking into account the nature, scope and purposes of the processing or categories of processing;

(g)	the risks to the rights and freedoms of data subjects; and

(h)	the right of data subjects to be informed about the restriction, unless that may be prejudicial to the purpose of the restriction.

CHAPTER IV

Controller and processor

Section 1

General obligations

Article 45

Transfers on the basis of an adequacy decision

1. A transfer of personal_data to a third country or an international_organisation may take place where the Commission has decided that the third country, a territory or one or more specified sectors within that third country, or the international_organisation in question ensures an adequate level of protection. Such a transfer shall not require any specific authorisation.

2. When assessing the adequacy of the level of protection, the Commission shall, in particular, take account of the following elements:

(a)

the rule of law, respect for human rights and fundamental freedoms, relevant legislation, both general and sectoral, including concerning public security, defence, national security and criminal law and the access of public authorities to personal_data, as well as the implementation of such legislation, data protection rules, professional rules and security measures, including rules for the onward transfer of personal_data to another third country or international_organisation which are complied with in that country or international_organisation, case-law, as well as effective and enforceable data subject rights and effective administrative and judicial redress for the data subjects whose personal_data are being transferred;

(b)

the existence and effective functioning of one or more independent supervisory authorities in the third country or to which an international_organisation is subject, with responsibility for ensuring and enforcing compliance with the data protection rules, including adequate enforcement powers, for assisting and advising the data subjects in exercising their rights and for cooperation with the supervisory authorities of the Member States; and

(c)

the international commitments the third country or international_organisation concerned has entered into, or other obligations arising from legally binding conventions or instruments as well as from its participation in multilateral or regional systems, in particular in relation to the protection of personal_data.

3. The Commission, after assessing the adequacy of the level of protection, may decide, by means of implementing act, that a third country, a territory or one or more specified sectors within a third country, or an international_organisation ensures an adequate level of protection within the meaning of paragraph 2 of this Article. The implementing act shall provide for a mechanism for a periodic review, at least every four years, which shall take into account all relevant developments in the third country or international_organisation. The implementing act shall specify its territorial and sectoral application and, where applicable, identify the supervisory_authority or authorities referred to in point (b) of paragraph 2 of this Article. The implementing act shall be adopted in accordance with the examination procedure referred to in Article 93(2).

4. The Commission shall, on an ongoing basis, monitor developments in third countries and international_organisations that could affect the functioning of decisions adopted pursuant to paragraph 3 of this Article and decisions adopted on the basis of Article 25(6) of Directive 95/46/EC.

5. The Commission shall, where available information reveals, in particular following the review referred to in paragraph 3 of this Article, that a third country, a territory or one or more specified sectors within a third country, or an international_organisation no longer ensures an adequate level of protection within the meaning of paragraph 2 of this Article, to the extent necessary, repeal, amend or suspend the decision referred to in paragraph 3 of this Article by means of implementing acts without retro-active effect. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 93(2).

On duly justified imperative grounds of urgency, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 93(3).

6. The Commission shall enter into consultations with the third country or international_organisation with a view to remedying the situation giving rise to the decision made pursuant to paragraph 5.

7. A decision pursuant to paragraph 5 of this Article is without prejudice to transfers of personal_data to the third country, a territory or one or more specified sectors within that third country, or the international_organisation in question pursuant to Articles 46 to 49.

8. The Commission shall publish in the Official Journal of the European Union and on its website a list of the third countries, territories and specified sectors within a third country and international_organisations for which it has decided that an adequate level of protection is or is no longer ensured.

9. Decisions adopted by the Commission on the basis of Article 25(6) of Directive 95/46/EC shall remain in force until amended, replaced or repealed by a Commission Decision adopted in accordance with paragraph 3 or 5 of this Article.

Article 50

International cooperation for the protection of personal_data

In relation to third countries and international_organisations, the Commission and supervisory authorities shall take appropriate steps to:

(a)	develop international cooperation mechanisms to facilitate the effective enforcement of legislation for the protection of personal_data;

(b)

provide international mutual assistance in the enforcement of legislation for the protection of personal_data, including through notification, complaint referral, investigative assistance and information exchange, subject to appropriate safeguards for the protection of personal_data and other fundamental rights and freedoms;

(c)	engage relevant stakeholders in discussion and activities aimed at furthering international cooperation in the enforcement of legislation for the protection of personal_data;

(d)	promote the exchange and documentation of personal_data protection legislation and practice, including on jurisdictional conflicts with third countries.

CHAPTER VI

Independent supervisory authorities

Section 1

Independent status

Article 57

Tasks

1. Without prejudice to other tasks set out under this Regulation, each supervisory_authority shall on its territory:

(a)	monitor and enforce the application of this Regulation;

(b)	promote public awareness and understanding of the risks, rules, safeguards and rights in relation to processing. Activities addressed specifically to children shall receive specific attention;

(c)	advise, in accordance with Member State law, the national parliament, the government, and other institutions and bodies on legislative and administrative measures relating to the protection of natural persons' rights and freedoms with regard to processing;

(d)	promote the awareness of controllers and processors of their obligations under this Regulation;

(e)	upon request, provide information to any data subject concerning the exercise of their rights under this Regulation and, if appropriate, cooperate with the supervisory authorities in other Member States to that end;

(f)

handle complaints lodged by a data subject, or by a body, organisation or association in accordance with Article 80, and investigate, to the extent appropriate, the subject matter of the complaint and inform the complainant of the progress and the outcome of the investigation within a reasonable period, in particular if further investigation or coordination with another supervisory_authority is necessary;

(g)	cooperate with, including sharing information and provide mutual assistance to, other supervisory authorities with a view to ensuring the consistency of application and enforcement of this Regulation;

(h)	conduct investigations on the application of this Regulation, including on the basis of information received from another supervisory_authority or other public authority;

(i)	monitor relevant developments, insofar as they have an impact on the protection of personal_data, in particular the development of information and communication technologies and commercial practices;

(j)	adopt standard contractual clauses referred to in Article 28(8) and in point (d) of Article 46(2);

(k)	establish and maintain a list in relation to the requirement for data protection impact assessment pursuant to Article 35(4);

(l)	give advice on the processing operations referred to in Article 36(2);

(m)	encourage the drawing up of codes of conduct pursuant to Article 40(1) and provide an opinion and approve such codes of conduct which provide sufficient safeguards, pursuant to Article 40(5);

(n)	encourage the establishment of data protection certification mechanisms and of data protection seals and marks pursuant to Article 42(1), and approve the criteria of certification pursuant to Article 42(5);

(o)	where applicable, carry out a periodic review of certifications issued in accordance with Article 42(7);

(p)	draft and publish the criteria for accreditation of a body for monitoring codes of conduct pursuant to Article 41 and of a certification body pursuant to Article 43;

(q)	conduct the accreditation of a body for monitoring codes of conduct pursuant to Article 41 and of a certification body pursuant to Article 43;

(r)	authorise contractual clauses and provisions referred to in Article 46(3);

(s)	approve binding_corporate_rules pursuant to Article 47;

(t)	contribute to the activities of the Board;

(u)	keep internal records of infringements of this Regulation and of measures taken in accordance with Article 58(2); and

(v)	fulfil any other tasks related to the protection of personal_data.

2. Each supervisory_authority shall facilitate the submission of complaints referred to in point (f) of paragraph 1 by measures such as a complaint submission form which can also be completed electronically, without excluding other means of communication.

3. The performance of the tasks of each supervisory_authority shall be free of charge for the data subject and, where applicable, for the data protection officer.

4. Where requests are manifestly unfounded or excessive, in particular because of their repetitive character, the supervisory_authority may charge a reasonable fee based on administrative costs, or refuse to act on the request. The supervisory_authority shall bear the burden of demonstrating the manifestly unfounded or excessive character of the request.

Article 62

Joint operations of supervisory authorities

1. The supervisory authorities shall, where appropriate, conduct joint operations including joint investigations and joint enforcement measures in which members or staff of the supervisory authorities of other Member States are involved.

2. Where the controller or processor has establishments in several Member States or where a significant number of data subjects in more than one Member State are likely to be substantially affected by processing operations, a supervisory_authority of each of those Member States shall have the right to participate in joint operations. The supervisory_authority which is competent pursuant to Article 56(1) or (4) shall invite the supervisory_authority of each of those Member States to take part in the joint operations and shall respond without delay to the request of a supervisory_authority to participate.

3. A supervisory_authority may, in accordance with Member State law, and with the seconding supervisory_authority's authorisation, confer powers, including investigative powers on the seconding supervisory_authority's members or staff involved in joint operations or, in so far as the law of the Member State of the host supervisory_authority permits, allow the seconding supervisory_authority's members or staff to exercise their investigative powers in accordance with the law of the Member State of the seconding supervisory_authority. Such investigative powers may be exercised only under the guidance and in the presence of members or staff of the host supervisory_authority. The seconding supervisory_authority's members or staff shall be subject to the Member State law of the host supervisory_authority.

4. Where, in accordance with paragraph 1, staff of a seconding supervisory_authority operate in another Member State, the Member State of the host supervisory_authority shall assume responsibility for their actions, including liability, for any damage caused by them during their operations, in accordance with the law of the Member State in whose territory they are operating.

5. The Member State in whose territory the damage was caused shall make good such damage under the conditions applicable to damage caused by its own staff. The Member State of the seconding supervisory_authority whose staff has caused damage to any person in the territory of another Member State shall reimburse that other Member State in full any sums it has paid to the persons entitled on their behalf.

6. Without prejudice to the exercise of its rights vis-à-vis third parties and with the exception of paragraph 5, each Member State shall refrain, in the case provided for in paragraph 1, from requesting reimbursement from another Member State in relation to damage referred to in paragraph 4.

7. Where a joint operation is intended and a supervisory_authority does not, within one month, comply with the obligation laid down in the second sentence of paragraph 2 of this Article, the other supervisory authorities may adopt a provisional measure on the territory of its Member State in accordance with Article 55. In that case, the urgent need to act under Article 66(1) shall be presumed to be met and require an opinion or an urgent binding decision from the Board pursuant to Article 66(2).

Section 2

Consistency

Article 99

Entry into force and application

1. This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

2. It shall apply from 25 May 2018.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 27 April 2016.

For the European Parliament

The President

M. SCHULZ

For the Council

The President

J.A. HENNIS-PLASSCHAERT

(1) OJ C 229, 31.7.2012, p. 90.

(2) OJ C 391, 18.12.2012, p. 127.

(3) Position of the European Parliament of 12 March 2014 (not yet published in the Official Journal) and position of the Council at first reading of 8 April 2016 (not yet published in the Official Journal). Position of the European Parliament of 14 April 2016.

(4) Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal_data and on the free movement of such data (OJ L 281, 23.11.1995, p. 31).

(5) Commission Recommendation of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises (C(2003) 1422) (OJ L 124, 20.5.2003, p. 36).

(6) Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal_data by the Community institutions and bodies and on the free movement of such data (OJ L 8, 12.1.2001, p. 1).

(7) Directive (EU) 2016/680 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal_data by competent authorities for the purposes of prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, and the free movement of such data and repealing Council Framework Decision 2008/977/JHA (see page 89 of this Official Journal).

(8) Directive 2000/31/EC of the European Parliament and of the Council of 8 June 2000 on certain legal aspects of information_society_services, in particular electronic commerce, in the Internal Market (‘Directive on electronic commerce’) (OJ L 178, 17.7.2000, p. 1).

(9) Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients' rights in cross-border healthcare (OJ L 88, 4.4.2011, p. 45).

(10) Council Directive 93/13/EEC of 5 April 1993 on unfair terms in consumer contracts (OJ L 95, 21.4.1993, p. 29).

(11) Regulation (EC) No 1338/2008 of the European Parliament and of the Council of 16 December 2008 on Community statistics on public health and health and safety at work (OJ L 354, 31.12.2008, p. 70).

(12) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).

(13) Regulation (EU) No 1215/2012 of the European Parliament and of the Council of 12 December 2012 on jurisdiction and the recognition and enforcement of judgments in civil and commercial matters (OJ L 351, 20.12.2012, p. 1).

(14) Directive 2003/98/EC of the European Parliament and of the Council of 17 November 2003 on the re-use of public sector information (OJ L 345, 31.12.2003, p. 90).

(15) Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (OJ L 158, 27.5.2014, p. 1).

(16) Regulation (EC) No 223/2009 of the European Parliament and of the Council of 11 March 2009 on European statistics and repealing Regulation (EC, Euratom) No 1101/2008 of the European Parliament and of the Council on the transmission of data subject to statistical confidentiality to the Statistical Office of the European Communities, Council Regulation (EC) No 322/97 on Community Statistics, and Council Decision 89/382/EEC, Euratom establishing a Committee on the Statistical Programmes of the European Communities (OJ L 87, 31.3.2009, p. 164).

(17) OJ C 192, 30.6.2012, p. 7.

(18) Directive 2002/58/EC of the European Parliament and of the Council of 12 July 2002 concerning the processing of personal_data and the protection of privacy in the electronic communications sector (Directive on privacy and electronic communications) (OJ L 201, 31.7.2002, p. 37).

(19) Directive (EU) 2015/1535 of the European Parliament and of the Council of 9 September 2015 laying down a procedure for the provision of information in the field of technical regulations and of rules on Information Society services (OJ L 241, 17.9.2015, p. 1).

(20) Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008, p. 30).

(21) Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (OJ L 145, 31.5.2001, p. 43).

whereas

(7) Those developments require a strong and more coherent data protection framework in the Union, backed by strong enforcement, given the importance of creating the trust that will allow the digital economy to develop across the internal market.
Natural persons should have control of their own personal_data.
Legal and practical certainty for natural persons, economic operators and public authorities should be enhanced.

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(80) Where a controller or a processor not established in the Union is processing personal_data of data subjects who are in the Union whose processing activities are related to the offering of goods or services, irrespective of whether a payment of the data subject is required, to such data subjects in the Union, or to the monitoring of their behaviour as far as their behaviour takes place within the Union, the controller or the processor should designate a representative, unless the processing is occasional, does not include processing, on a large scale, of special categories of personal_data or the processing of personal_data relating to criminal convictions and offences, and is unlikely to result in a risk to the rights and freedoms of natural persons, taking into account the nature, context, scope and purposes of the processing or if the controller is a public authority or body.
The representative should act on behalf of the controller or the processor and may be addressed by any supervisory_authority.
The representative should be explicitly designated by a written mandate of the controller or of the processor to act on its behalf with regard to its obligations under this Regulation.
The designation of such a representative does not affect the responsibility or liability of the controller or of the processor under this Regulation.
Such a representative should perform its tasks according to the mandate received from the controller or processor, including cooperating with the competent supervisory authorities with regard to any action taken to ensure compliance with this Regulation.
The designated representative should be subject to enforcement proceedings in the event of non-compliance by the controller or processor.

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(86) The controller should communicate to the data subject a personal_data breach, without undue delay, where that personal_data breach is likely to result in a high risk to the rights and freedoms of the natural person in order to allow him or her to take the necessary precautions.
The communication should describe the nature of the personal_data breach as well as recommendations for the natural person concerned to mitigate potential adverse effects.
Such communications to data subjects should be made as soon as reasonably feasible and in close cooperation with the supervisory_authority, respecting guidance provided by it or by other relevant authorities such as law-enforcement authorities.
For example, the need to mitigate an immediate risk of damage would call for prompt communication with data subjects whereas the need to implement appropriate measures against continuing or similar personal_data breaches may justify more time for communication.

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(88) In setting detailed rules concerning the format and procedures applicable to the notification of personal_data breaches, due consideration should be given to the circumstances of that breach, including whether or not personal_data had been protected by appropriate technical protection measures, effectively limiting the likelihood of identity fraud or other forms of misuse.
Moreover, such rules and procedures should take into account the legitimate interests of law-enforcement authorities where early disclosure could unnecessarily hamper the investigation of the circumstances of a personal_data breach.

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(116) When personal_data moves across borders outside the Union it may put at increased risk the ability of natural persons to exercise data protection rights in particular to protect themselves from the unlawful use or disclosure of that information.
At the same time, supervisory authorities may find that they are unable to pursue complaints or conduct investigations relating to the activities outside their borders.
Their efforts to work together in the cross-border context may also be hampered by insufficient preventative or remedial powers, inconsistent legal regimes, and practical obstacles like resource constraints.
Therefore, there is a need to promote closer cooperation among data protection supervisory authorities to help them exchange information and carry out investigations with their international counterparts.
For the purposes of developing international cooperation mechanisms to facilitate and provide international mutual assistance for the enforcement of legislation for the protection of personal_data, the Commission and the supervisory authorities should exchange information and cooperate in activities related to the exercise of their powers with competent authorities in third countries, based on reciprocity and in accordance with this Regulation.

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(127) Each supervisory_authority not acting as the lead supervisory_authority should be competent to handle local cases where the controller or processor is established in more than one Member State, but the subject matter of the specific processing concerns only processing carried out in a single Member State and involves only data subjects in that single Member State, for example, where the subject matter concerns the processing of employees' personal_data in the specific employment context of a Member State.
In such cases, the supervisory_authority should inform the lead supervisory_authority without delay about the matter.
After being informed, the lead supervisory_authority should decide, whether it will handle the case pursuant to the provision on cooperation between the lead supervisory_authority and other supervisory authorities concerned (‘one-stop-shop mechanism’), or whether the supervisory_authority which informed it should handle the case at local level.
When deciding whether it will handle the case, the lead supervisory_authority should take into account whether there is an establishment of the controller or processor in the Member State of the supervisory_authority which informed it in order to ensure effective enforcement of a decision vis-à-vis the controller or processor.
Where the lead supervisory_authority decides to handle the case, the supervisory_authority which informed it should have the possibility to submit a draft for a decision, of which the lead supervisory_authority should take utmost account when preparing its draft decision in that one-stop-shop mechanism.

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(129) In order to ensure consistent monitoring and enforcement of this Regulation throughout the Union, the supervisory authorities should have in each Member State the same tasks and effective powers, including powers of investigation, corrective powers and sanctions, and authorisation and advisory powers, in particular in cases of complaints from natural persons, and without prejudice to the powers of prosecutorial authorities under Member State law, to bring infringements of this Regulation to the attention of the judicial authorities and engage in legal proceedings.
Such powers should also include the power to impose a temporary or definitive limitation, including a ban, on processing.
Member States may specify other tasks related to the protection of personal_data under this Regulation.
The powers of supervisory authorities should be exercised in accordance with appropriate procedural safeguards set out in Union and Member State law, impartially, fairly and within a reasonable time.
In particular each measure should be appropriate, necessary and proportionate in view of ensuring compliance with this Regulation, taking into account the circumstances of each individual case, respect the right of every person to be heard before any individual measure which would affect him or her adversely is taken and avoid superfluous costs and excessive inconveniences for the persons concerned.
Investigatory powers as regards access to premises should be exercised in accordance with specific requirements in Member State procedural law, such as the requirement to obtain a prior judicial authorisation.
Each legally binding measure of the supervisory_authority should be in writing, be clear and unambiguous, indicate the supervisory_authority which has issued the measure, the date of issue of the measure, bear the signature of the head, or a member of the supervisory_authority authorised by him or her, give the reasons for the measure, and refer to the right of an effective remedy.
This should not preclude additional requirements pursuant to Member State procedural law.
The adoption of a legally binding decision implies that it may give rise to judicial review in the Member State of the supervisory_authority that adopted the decision.

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(133) The supervisory authorities should assist each other in performing their tasks and provide mutual assistance, so as to ensure the consistent application and enforcement of this Regulation in the internal market.
A supervisory_authority requesting mutual assistance may adopt a provisional measure if it receives no response to a request for mutual assistance within one month of the receipt of that request by the other supervisory_authority.

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(137) There may be an urgent need to act in order to protect the rights and freedoms of data subjects, in particular when the danger exists that the enforcement of a right of a data subject could be considerably impeded.
A supervisory_authority should therefore be able to adopt duly justified provisional measures on its territory with a specified period of validity which should not exceed three months.

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(148) In order to strengthen the enforcement of the rules of this Regulation, penalties including administrative fines should be imposed for any infringement of this Regulation, in addition to, or instead of appropriate measures imposed by the supervisory_authority pursuant to this Regulation.
In a case of a minor infringement or if the fine likely to be imposed would constitute a disproportionate burden to a natural person, a reprimand may be issued instead of a fine.
Due regard should however be given to the nature, gravity and duration of the infringement, the intentional character of the infringement, actions taken to mitigate the damage suffered, degree of responsibility or any relevant previous infringements, the manner in which the infringement became known to the supervisory_authority, compliance with measures ordered against the controller or processor, adherence to a code of conduct and any other aggravating or mitigating factor.
The imposition of penalties including administrative fines should be subject to appropriate procedural safeguards in accordance with the general principles of Union law and the Charter, including effective judicial protection and due process.

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